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Mehta, Anirudh, Saurabh Dani, and Alaka Godbole. "A multicentre, randomized, double blind, placebo controlled pilot study to evaluate the efficacy and safety of colloidal Nano silver gel (SilverSol) in the treatment of bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis." Indian Journal of Obstetrics and Gynecology Research 11, no. 1 (February 15, 2024): 83–89. http://dx.doi.org/10.18231/j.ijogr.2024.015.
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The study evaluated the efficacy and safety of colloidal nano silver gel (SilverSol Vagigel) (A patented technology from American Biotech Labs, USA) in combination with 0.2% lactic acid in the female subjects for the treatment of vaginal infections.This study was a multicenter, randomized, double-blind, placebo-controlled pilot study in which post-menarchal female subjects between 18 and 65 years of age clinically diagnosed with bacterial vaginosis and vulvovaginal candidiasis were enrolled. The participants were randomized to receive treatment with SilverSol Vagigel or placebo (vehicle) gel (both treatments as one 4 gm application inserted into the vagina with an applicator device, once daily at bedtime for internal use and 2 gm gel for local application to the vulva and vagina for external use twice daily for a period of 14 days). The primary endpoint evaluated was the proportion of subjects achieving clinical cure. The secondary endpoint was the proportion of subjects achieving microbiological cure at the end of the study visit. A total of 57 subjects were randomized in the study out of which 38 subjects were randomized in SilverSol Vagigel arm and 19 subjects were randomized in placebo arm. SilverSol Vagigel significantly improved cure rates of vaginal infections compared to placebo. The proportion of subjects achieving clinical cure of vaginal infections was higher i.e., 33 (86.84%) subjects in SilverSol Vagigel arm compared to 07 (41.18%) subjects in Placebo gel arm (p-value: 0.0009). The clinical cure rate with SilverSol Vagigel was 81.82% (P=0.1758) for bacterial vaginosis and 92.59% (P=0.0010) for vulvovaginal candidiasis patients at the end of the study. Overall SilverSol Vagigel treatment resulted in a significantly higher microbial cure of vaginal infections (P=0.0028) compared to placebo, with a microbial cure rate of 100% for bacterial vaginosis (P=0.0330) and 85.19% for vulvovaginal candidiasis (P=0.0097). No adverse events were reported in subjects treated with SilverSol Vagigel.Colloidal Nano Silver Gel (SilverSol Vagigel) was effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis.
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Bulavenko, O. V., V. O. Rud, and S. A. Bosui. "Vaginal gel Lactagel in correction of vaginal biocenosis in patients after gynecological operations." HEALTH OF WOMAN, no. 7(123) (September 30, 2017): 116–18. http://dx.doi.org/10.15574/hw.2017.123.116.
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The objective: to evaluate the clinical efficacy of using Lactagel for the correction of vaginal biocenosis in patients after gynecological operations. Patients and methods: 50 women of reproductive age with a violation of biocenosis of the vagina, which occurred after gynecological operations, participated in the study. We evaluated the clinical efficacy of the treatment after its conducting using the microbiological and clinical criteria of effectiveness: 1) the dynamics of the subjective signs of bacterial vaginosis on the visual-analog scale in the first day after the operation and before discharge; 2) reduction of the number of objective clinical criteria of Amsel; 3) the dynamics of vaginal biopsy. We use vaginal gel Lactagel according to the scheme: 5 ml intravaginally one time per day for 7 days for the treatment. Results: The numerical values of the visual analog scale showed that after treatment with Lactagel in 64% of the patients the selection was absent or not significant; the smell of secretions was absent in all patients; moderate itching and burning were absent in all patients. Before the discharge, According to Amsel criteria, the vaginal discharge was determined in eight women (16%); PHі4.5 - in three (6%); a positive KOH test is two (4%), «key» cells in two women (4%). The median concentration of Lactobacillus spp. 105-107 CFU/ml, while Gardenella vaginalis and Atopobium vaginae reached <104 CFU/ml after the treatment. Conclusion: According to the analysis of the severity of clinical manifestations on the visual-analog scale; The number of objective clinical criteria of the Amelia, the dynamics of vaginal biopsy, we can recommend Laktagel for widespread use in clinical practice. Key words: vaginal biocenosis, postoperative period, dysbiosis, bacterial vaginosis, lactobacilli, Lactagel.
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Strandberg, Kristi L., Marnie L. Peterson, Ying-Chi Lin, Melinda C. Pack, David J. Chase, and Patrick M. Schlievert. "Glycerol Monolaurate Inhibits Candida and Gardnerella vaginalis In Vitro and In Vivo but Not Lactobacillus." Antimicrobial Agents and Chemotherapy 54, no. 2 (December 14, 2009): 597–601. http://dx.doi.org/10.1128/aac.01151-09.
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ABSTRACT We investigated the effects of glycerol monolaurate (GML) on Lactobacillus, Candida, and Gardnerella vaginalis human vaginal microflora. Our previous work demonstrated that 6 months of GML treatment vaginally does not alter lactobacillus counts in monkeys. Candida and G. vaginalis are commonly associated with vaginal infections in women, many becoming chronic or recurrent. In vitro growth inhibition studies determined the effects of GML (0 to 500 μg/ml) against multiple Candida species and G. vaginalis. A randomized, double-blind study investigated the effects of GML on vaginal microflora Lactobacillus, Candida, and G. vaginalis in colonized or infected women (n = 36). Women self-administered intravaginal gels containing 0% (n = 14), 0.5% (n = 13), or 5% (n = 9) GML every 12 h for 2 days. Vaginal swabs were collected before and immediately after the first gel administration and 12 h after the final gel administration. Swabs were tested for Lactobacillus, Candida, G. vaginalis, and GML. In vitro GML concentrations of 500 μg/ml were candicidal for all species tested, while a concentration of 10 μg/ml was bactericidal for G. vaginalis. Control and GML gels applied vaginally in women did not alter vaginal pH or Lactobacillus counts. Control gels reduced G. vaginalis counts but not Candida counts, whereas GML gels reduced both Candida and G. vaginalis. No adverse events were reported by participating women. GML is antimicrobial for Candida and G. vaginalis in vitro. Vaginal GML gels in women do not affect Lactobacillus negatively but significantly reduce Candida and G. vaginalis.
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Provotorova, T. V. "Analysis of long-term results of Metrogil vaginal gel and Metrogil plus in the treatment of recurrent vaginal biocenosis disorders." Obstetrics, Gynecology and Reproduction 12, no. 2 (August 27, 2018): 32–38. http://dx.doi.org/10.17749/2313-7347.2018.12.2.032-038.
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Aim: to study the efficacy of Metrogil vaginal gel and Metrogil plus in patients with recurrent vaginal biocenosis disorders. Materials and methods. A total of 234 patients were examined. Among them, 115 women with mixed flora without Candida spp in their vaginal microbiome, received Metrogil vaginal gel treatment (group 1), and 119 women with mixed flora and Candida spp. in their vaginal microbiome, received treatment with Metrogil plus applied as an intravaginal gel (group 2). To assess the treatment efficacy, patients’ complaints, objective examination data, pH-metry, smear microscopy, and polymerase chain reaction (PCR) results were analyzed. Results. In the vaginal microbiome of all patients before treatment, the presence of heterogeneous gram-positive and gram-negative flora was detected; among those bacteria, a markedly decreased presence of Lactobacillus spp. (to 102-103 cfu/ml) and a dramatically increased presence of Gardnerella vaginalis, Atopobium vaginae, Mobiluncus spp. was found; there was also a significant amount of Candida spp. in patients of group 2. By the end of the treatment, the patients presented no complaints, there were no objective clinical symptoms, the pH values came to normal, and the PCR results showed an improvement in the qualitative and quantitative composition of the vaginal microflora. In most patients, this positive result persisted for 3 months. Conclusion. The decision on pharmacotherapy in patients with recurrent disbalance of vaginal biocenosis should be based on the qualitative composition of the vaginal microbiome.
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Uvarova, E. V., and Z. K. Batyrova. "Advantage of complex correction of vaginal microbiocenosis at an early reproductive age." Medical Council, no. 13 (October 10, 2019): 142–47. http://dx.doi.org/10.21518/2079-701x-2019-13-142-147.
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Aim of the study: evaluation of the effectiveness of the integrated use of the Vagilac line of intimate hygiene products in young women with bacterial vaginosis (BV). Design of the study: prospective randomized intervention open study. Materials and methods: 45 menstruating young women diagnosed with «BW» at the age of 11-17 years, divided into 3 equal groups, were examined. In the 1st group adolescents received oral probiotic with Lactobacillus rhamnosus GR-1® and Lactobacillus reuteri RC-14® within 15 days, in the 2nd group within 30 days. Group 3 girls, along with probiotic, used liquid soap and Vagilac moisturising gel with lactic acid for intimate hygiene for 30 days. Diagnosis and control of the results were assessed taking into account complaints, vulvovaginoscopy, pH-metry, microscopy and molecular-genetic examination of vaginal microbiocenosis. Results: 1 month after the end of oral probiotic use, the share of Lactobacillus spp. in vaginal TBM in girls who received the probiotic within 15 days was 21.3%, 30 days 53.4%. The parallel use of liquid soap and Vagilac gel for intimate hygiene was manifested by the steady normalization of lactobacillus representation in the vagina. Conclusion: In the case of bacterial vaginosis in young girls, the most appropriate way to restore vaginal normocenosis was to use an oral probiotic with Lactobacillus rhamnosus GR-1® and Lactobacillus reuteri RC-14® for 30 days with the addition of liquid soap and Vagilac moisturising gel for intimate hygiene.
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Oliveira, Laura Maria Andrade, Cláudio Galuppo Diniz, Aline Augusta Sampaio Fernandes, Daniele Maria Knupp Souza-Sotte, Michelle Cristine Ribeiro Freitas, Alessandra Barbosa Ferreira Machado, and Vania Lucia Silva. "Assessment of vaginal microbiota in Brazilian women with and without bacterial vaginosis and comparison with Nugent score." Journal of Infection in Developing Countries 12, no. 02 (February 28, 2018): 127–36. http://dx.doi.org/10.3855/jidc.9532.
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Introduction: Bacterial vaginosis (BV) is characterized by the depletion of Lactobacillus spp. population and increase of other species, especially Gardnerella vaginalis and Atopobium vaginae. This study aimed to investigate the vaginal microbiota structure of Brazilian women with and without BV according to Nugent Score and to assess the correlation among Nugent score and the quantification of BV-associated bacteria.
Methodology: Polymerase Chain Reaction-Denaturing Gradient Gel Electrophoresis (PCR-DGGE) assay was employed to characterize the vaginal microbiota structure. Quantification of Lactobacillus spp., G. vaginalis, A. vaginae, Mobiluncus sp. and M. hominis were determined by quantitative real-time PCR (qPCR).
Results: Clustering by PCR-DGGE revealed differences in microbial structure of the different patient groups. Gardnerella vaginalis, A. vaginae, M. hominis and Mobiluncus sp. were detected at high loads in BV-associated microbiota. Quantification of Lactobacillus spp. showed an inverse correlation with Nugent score while the loads of G. vaginalis, A. vaginae, M. hominis and Mobiluncus sp. indicated a direct correlation with this method.
Conclusions: Despite Nugent score is considered the gold standard for BV diagnosis, qPCR stands out as a useful tool for bacteria quantification and an alternative for BV diagnosis. Vaginal microbiota is a complex microbial community although there is a common core among BV and non-BV women. Investigation of vaginal microbiota structure may contribute to the development of tools for diagnosis improvement and therapeutic regimen optimization.
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Kenney, Jessica, Aixa Rodríguez, Larisa Kizima, Samantha Seidor, Radhika Menon, Ninochka Jean-Pierre, Pavel Pugach, et al. "A Modified Zinc Acetate Gel, a Potential Nonantiretroviral Microbicide, Is Safe and Effective against Simian-Human Immunodeficiency Virus and Herpes Simplex Virus 2 InfectionIn Vivo." Antimicrobial Agents and Chemotherapy 57, no. 8 (June 10, 2013): 4001–9. http://dx.doi.org/10.1128/aac.00796-13.
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ABSTRACTWe previously showed that a prototype gel comprising zinc acetate (ZA) in carrageenan (CG) protected mice against vaginal and rectal herpes simplex virus 2 (HSV-2) challenge as well as macaques against vaginal simian-human immunodeficiency virus reverse transcriptase (SHIV-RT) challenge. In this work, we modified buffers and cosolvents to obtain a stable, nearly iso-osmolal formulation and evaluated its safety and efficacy against SHIV-RT and HSV-2.In vitrotoxicity to lactobacilli andCandida albicanswas determined. Macaques were given daily doses of ZA and CG (ZA/CG) or CG alone vaginally for 14 days and challenged with SHIV-RT 24 h later. Mice were challenged vaginally or rectally with HSV-2 immediately after a single gel treatment to measure efficacy or vaginally 12 h after daily gel treatment for 7 days to evaluate the gel's impact on susceptibility to HSV-2 infection. The modified ZA/CG neither affected the viability of lactobacilli orC. albicansnor enhanced vaginal HSV-2 infection after daily ZA/CG treatment. Vaginal SHIV-RT infection of macaques was reduced by 66% (P= 0.006) when macaques were challenged 24 h after the last dose of gel. We observed 60% to 80% uninfected mice after vaginal (P< 0.0001) and rectal (P= 0.008) high-dose HSV-2 challenge. The modified ZA/CG gel is safe and effective in animal models and represents a potential candidate to limit the transmission of HIV and HSV-2.
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Mardikasari, Sandra Aulia, Arfian Junior Amir, Aliyah ., Muhammad Nur Amir, Achmad Himawan, Usmanengsih ., Suci Ananda Putri, Irma Nurfadilla Tuany, and Andi Dian Permana. "DEVELOPMENT OF METRONIDAZOLE MICROSPONGE INCORPORATED INTO CARBOMER-BASED VAGINAL GEL." Journal of Experimental Biology and Agricultural Sciences 9, Spl-2-ICOPMES_2020 (September 8, 2021): S241—S247. http://dx.doi.org/10.18006/2021.9(spl-2-icopmes_2020).s241.s247.
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Bacterial vaginosis (BV) is a vaginal infection caused by excessive bacterial growth, thus disrupting the natural balance of bacteria inside the vagina. Metronidazole becomes a drug of choice and a widely prescribed drug for the treatment of BV. However, when applied topically, metronidazole has a low vaginal residence time because of the natural washing mechanism of the vagina. This study aimed to improve the retention time of metronidazole inside the vagina and control its release profile. This study was prepared 4 formulas of gel for metronidazole microsponges with some concentration ratio of carbomer and triethanolamine. The evaluations carried out to test the efficacy of the developed formulation included organoleptic, pH measurement, spreadability, viscosity, mucoadhesive properties, permeation test using Franz diffusion cell and retention test. The results showed that the gel appearance was white, odourless and homogenous. The characteristics of all prepared gel for pH, viscosity, spreadability, and mucoadhesive ability were appropriate to the required standard for vaginal delivery. The permeation and retention test showed that F3 with the carbomer and triethanolamine concentration of 1.25%: 1.75% was able to retain and controlled the drug release locally in the vaginal mucosa. This study provides an alternative strategy in drug formulation for the treatment of BV.
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Stryha, O. A., G. V. Zaychenko, S. I. Savosko, and K. Y. Sorokopud. "THE INVESTIGATION OF PHARMACOLOGICAL PROPERTIES OF VAGINAL GEL WITH RESVERATROL AND HYALURONIC ACID IN CONDITIONS OF EXPERIMENTAL HYPOESTROGENIC STATE IN RATS." Medical Science of Ukraine (MSU) 17, no. 1 (March 30, 2021): 74–82. http://dx.doi.org/10.32345/2664-4738.1.2021.10.
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Relevance. The menopausal period due to irreversible loss of ovarian function is accompanied by various clinical symptoms and systemic changes. In turn, hormone replacement therapy has a number of contraindications and side effects, so now there is a need to find and create prophylactic and therapeutic agents based on natural compounds that are related to β-estrogen receptors. Vaginal gel with resveratrol and hyaluronic acid can reduce atrophic manifestations of the vaginal mucosa and affect various symptoms of menopause. However, the nature of the effect, dosage, and consequences of long-term use of resveratrol need further study.
Objective: to study pharmacological properties of a new vaginal gel with resveratrol and hyaluronic acid (HA) in a model of hypoestrogenism in ovariectomized rats.
Materials and methods. The experiments were performed on 24 outbred white nonlinear female rats, which were divided into 4 groups: intact control, controlled pathology, controlled pathology, and administration of resveratrol with hyaluronic acid, controlled pathology, and administration of a comparison drug with synthetic estrogen. The effectiveness of the drugs was assessed by their effect on the blood levels of the sex hormones estrogen and progesterone, on body weight, on body temperature, on the pH of vaginal secretions, on the state of the vaginal mucosa.
Results. 28-day vaginal injection of gel with resveratrol and hyaluronic acid slowed down and normalized weight gain of ovariectomized female rats, stabilized skin temperature and induced normalization of the pH of vaginal secretions of the vagina, normalized the level of sex hormones in the blood, promoted the restoration of the epithelial plate of the vagina.
Conclusions. The results showed the feasibility of developing and using a new vaginal gel with resveratrol as an alternative to hormone-containing drugs for the prevention or treatment of pathological hypoestrogenic conditions arising from estrogen deficiency.
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Kumar, Abhijeet, and Raju Agarwal. "Role and efficacy of vaginal dinoprostone gel (PGE2) plus vaginal misoprostol (PGE1) in second trimester termination of pregnancy." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 7, no. 3 (February 27, 2018): 888. http://dx.doi.org/10.18203/2320-1770.ijrcog20180455.
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Background: The addition of dinoprostone gel (PGE2) to standard regimen of second trimester abortion using vaginal misoprostol (PGE1) reduces failure rate and decrease induction abortion time interval. We evaluated the role and efficacy of vaginal dinoprostone gel with vaginal misoprostol in women undergoing second trimester abortion. Objective of present study was to assess the safety and effectiveness of vaginal dinoprostone gel plus vaginal misoprostol for second trimester termination of pregnancy.Methods: This study was a prospective cohort involving 100 women with 12-20 weeks gestation requesting termination of pregnancy. In study group 0.5mg dinoprostone gel applied vaginally followed by 400µg misoprostol every four hourly (max 3 doses) after six hours of dinoprostone gel application. The mean age of the women study was 27.2 years and mean gestational age was 18.9 weeks. The primary effectiveness of the study was the efficacy of the treatment to terminate pregnancy at 20 hrs. Secondary outcomes were induction abortion interval, failure rate, side effects. statistical analysis of study was carried out using chi square test.Results: At 20 hours, the complete abortion rate was 100%. Within 16 hours 98% women aborted without any significant side effects. Mean induction abortion interval was 14.56 hours.Conclusions: Combination of vaginal dinoprostone gel (PGE2) plus misoprostol (PGE1) is effective, safe and alternate method for second trimester pregnancy termination with. In this protocol induction to abortion interval time is less as compared to other methods of second trimester pregnancy termination.
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Tiwari, Sarika Sharma, Shailesh K. Gupta, Sumeet Dwivedi, and Raghvendra Dubey. "Formulation and evaluation of in situ herbal gel containing aqueous and methanolic extract of fruits of Quercus infectoria Oliv. for vaginal application." Journal of Drug Delivery and Therapeutics 8, no. 5 (September 14, 2018): 495–503. http://dx.doi.org/10.22270/jddt.v8i5.1913.
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Conventional vaginal dosage forms frequently produce leakages and drip. There is a need for the development of innovative vaginal formulation technology that fulfills certain criteria such as desirable product dispersion throughout the vagina, retention for intended intervals, and adequate release of drug. These features can be achieved by the use of bioadhesive based novel delivery systems. In-situ gelation is a process of gel formation at the site of application after the composition or formulation has been applied the site. Formulation and evaluation of one such bioadhesive based novel drug delivery system for an effective and patient friendly use of an antifungal drug to formulated In-situ gel. Quercus infectoria is medicinally important plant grown wildly in India and is useful in the treatment of fungal and microbial infection by tribal’s of India. The plant is used by tribal women to treat vaginal infection as mentioned in folk-lore. Therefore, the present plant as selected to formulate in-situ herbal gel using Quercus infectoria as active ingredients for the treatment of vaginal infection.
Keywords: Herbal Gels, Quercus infectoria, bioadhesive, vaginal drug delivery
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Shetty, Ektha M., and Asha Neravi. "A comparative study of vaginal misoprostol, dinoprostone gel, foley catheter, extra amniotic saline infusion along with vaginal misoprostol for induction of labor at term." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 9, no. 9 (August 27, 2020): 3683. http://dx.doi.org/10.18203/2320-1770.ijrcog20203840.
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Background: Objective of this study was to study the effect of vaginal misoprostol, dinoprostone gel, foley catheter, extra amniotic saline infusion along with vaginal misoprostol for induction of labor at term on maternal and fetal outcome.Methods: A one-year prospective observational study was conducted in the department of obstetrics and gynecology, SDM College of Medical Science and Hospital, Dharwad. Totally 100 postdated primigravida women with singleton gestation, vertex presentation and intact membrane who were induced with any four methods of induction 1) Tab. misoprostol 25 µg vaginally, 2) Intracervical dinoprostone gel, 3) Foley catheter and 4) Extra amniotic saline infusion along with tab. misoprostol 25 µg vaginally with 25 patients selected in each group, by random allocation technique and included in the study. Outcome measures analysed were the demographic profile, bishop score, induction to delivery interval, mode of delivery, maternal and fetal complications. Statistical analysis was done using SPSS 17 software.Results: Mean induction delivery interval was significant between PGE1 versus foley group (p=0.0034). In this study, 60% patients in dinoprostone group had Vaginal delivery and 72% in the EASI + misoprostol group underwent cesarean section (p=0.0372). NICU admission was maximum with EASI + vaginal misoprostol group and minimum with vaginal misoprostol alone.Conclusions: The groups were comparable with respect to maternal age, bishop score and fetal weight. The vaginal misoprostol group had shortest induction delivery interval. The maximum number of patients in dinoprostone gel group underwent vaginal delivery with a highest cesarean section and NICU admission with the EASI + misoprostol group.
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Schlievert, Patrick M., Kristi L. Strandberg, Amanda J. Brosnahan, Marnie L. Peterson, Stefan E. Pambuccian, Karla R. Nephew, Kevin G. Brunner, Nancy J. Schultz-Darken, and Ashley T. Haase. "Glycerol Monolaurate Does Not Alter Rhesus Macaque (Macaca mulatta) Vaginal Lactobacilli and Is Safe for Chronic Use." Antimicrobial Agents and Chemotherapy 52, no. 12 (October 6, 2008): 4448–54. http://dx.doi.org/10.1128/aac.00989-08.
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ABSTRACT Glycerol monolaurate (GML) is a fatty acid monoester that inhibits growth and exotoxin production of vaginal pathogens and cytokine production by vaginal epithelial cells. Because of these activities, and because of the importance of cytokine-mediated immune activation in human immunodeficiency virus type 1 (HIV-1) transmission to women, our laboratories are performing studies on the potential efficacy of GML as a topical microbicide to interfere with HIV-1 transmission in the simian immunodeficiency virus-rhesus macaque model. While GML is generally recognized as safe by the FDA for topical use, its safety for chronic use and effects on normal vaginal microflora in this animal model have not been evaluated. GML was therefore tested both in vitro for its effects on vaginal flora lactobacilli and in vivo as a 5% gel administered vaginally to monkeys. In vitro studies demonstrated that lactobacilli are not killed by GML; GML blocks the loss of their viability in stationary phase and does not interfere with lactic acid production. GML (5% gel) does not quantitatively alter monkey aerobic vaginal microflora compared to vehicle control gel. Lactobacilli and coagulase-negative staphylococci are the dominant vaginal aerobic microflora, with beta-hemolytic streptococci, Staphylococcus aureus, and yeasts sporadically present; gram-negative rods are not part of their vaginal flora. Colposcopy and biopsy studies indicate that GML does not alter normal mucosal integrity and does not induce inflammation; instead, GML reduces epithelial cell production of interleukin 8. The studies suggest that GML is safe for chronic use in monkeys when applied vaginally; it does not alter either mucosal microflora or integrity.
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Janssen, Laura E., Rubin J. T. Verduin, Christianne J. M. de Groot, Martijn A. Oudijk, and Marjon A. de Boer. "The association between vaginal hygiene practices and spontaneous preterm birth: A case-control study." PLOS ONE 17, no. 6 (June 30, 2022): e0268248. http://dx.doi.org/10.1371/journal.pone.0268248.
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Background Spontaneous preterm birth (SPTB) is a major cause of neonatal morbidity and mortality worldwide and defining its risk factors is necessary to reduce its prevalence. Recent studies have pointed out that bacterial vaginosis, a disturbance in the vaginal microbiome, is associated with SPTB. It is hypothesized that vaginal hygiene practices can alter the vaginal microbiome and are therefore associated with SPTB, but there are no studies investigating this matter. Methods and findings A case-control study was conducted between August 2018 and July 2021 in two affiliated university medical centers in Amsterdam, the Netherlands. We included a total of 79 women with a SPTB and compared them with 156 women with a term birth. Women with uterine anomalies, a history of cervical surgery or major congenital anomalies of the fetus were excluded. All participants filled in a questionnaire about vaginal washing with water, soap or gel, the use of intravaginal douches and vaginal steaming, both before and during pregnancy. Most women washed vaginally with water, 144 (61.3%) women before pregnancy and 135 (57.4%) women during pregnancy. A total of 43 (18.3%) washed with soap before and 36 (15.3%) during pregnancy. Before pregnancy, 40 (17.0%) women washed with vaginal gel and 27 (11.5%) during pregnancy. We found that the use of vaginal gel before pregnancy (aOR 2.29, 95% CI: 1.08–4.84) and even more during pregnancy, was associated with SPTB (aOR 3.45, 95% CI: 1.37–8.67). No association was found between washing with water or soap, intravaginal douching, or vaginal steaming and SPTB. Conclusions Our findings suggest that the use of vaginal gel is associated with SPTB. Women should be informed that vaginal use of gels might not be safe.
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Parvinroo, Shirin, Maede Eslami, Heshmatollah Ebrahimi-Najafabadi, and Zahra Hesari. "Natural polymers for vaginal mucoadhesive delivery of vinegar, using design of experiment methods." Vojnosanitetski pregled, no. 00 (2020): 121. http://dx.doi.org/10.2298/vsp200804121p.
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Background/Aim. Vinegars are of the main international traditional nutraceuticals which have been used as vaginal health protectant due to vagina pH balance maintenance and antimicrobial properties. Since the main used form of vinegar was liquid, it was difficult for vaginal application with low residence time; in this study a vaginal mucoadhesive gel of vinegar was designed. Methods. Xanthan gum (XG) and tragacanth (TG) were utilized as natural gel forming polymers. The effects of Xanthan gum and tragacanth on mucoadhesion strength and drug release of the gel formulations were optimized using a 3 level (32) factorial design. Several physico-chemical properties of the gel formulations including gel viscosity, spreadability, scanning electron microscopy (SEM) images of hydrogel chains, and release kinetic were also investigated. Results. demonstrated that tragacanth possesses a statistically significant effect on release rate control (p-value=0.0027) while both tragacanth and xanthan gum have significant effect (p value= 0.0001 and 0.0017, respectively) on mucoadhesion property. Conclusion. Design of experiment suggested that formulation F7 with 5% xanthan gum and 1% tragacanth (mucoadhesion = 0.4632 N and release rate = 88.8% in 6 hours) can be considered as the optimum formulation with some modifications.
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Nesalin, J. Adlin Jino, and Shafiya Khanum. "CURCUMIN LOADED POLYMERIC MICROSPHERES FOR VAGINAL DELIVERY: FORMULATION DESIGN, IN VITRO EVALUATION, KINETICS AND STABILITY STUDIES." Journal of Pharmaceutical and Scientific Innovation 10, no. 2 (April 14, 2021): 56–60. http://dx.doi.org/10.7897/2277-4572.102206.
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The main objective of this research is to evaluate a new approach for the preparation of bio adhesive microparticles and to design an innovative vaginal delivery system for curcumin which is able to enhance the drug anticancer activity. Curcumin encapsulated microspheres were prepared by solvent evaporation method. The microspheres were found to be discrete, spherical with free-flowing properties and evaluated for particle size analysis, shape (scanning electron microscopy), drug encapsulation efficiency, FTIR, DSC studies and in vitro release performance. The best selected microsphere formulation (F2, containing drug: polymer ratio 1:2) was incorporated into gels with a bio adhesive polymer. The microencapsulated vaginal gels were evaluated for pH, spreadability, extrudability, viscosity, in vitro drug release, drug release kinetics, bio adhesion test, accelerated stability of selected gel formulation. In vitro drug release rate for selected microencapsulated bio adhesive vaginal gel (FS3 gel, containing 1 % w/w of drug loaded microspheres and 0.6 % w/w of Carbopol 934) was found to sustain curcumin over 12h. The results were then compared statistically and obtained a satisfactory correlation. Thus, in conclusion preparation protocol of microencapsulated vaginal gel study may be adopted for a successful development of newer drug delivery system of other drugs for administration to vagina.
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Merriam, Kathryn S., Kristina A. Leake, Mollie Elliot, Michelle L. Matthews, Rebecca S. Usadi, and Bradley S. Hurst. "Sexual Absorption of Vaginal Progesterone: A Randomized Control Trial." International Journal of Endocrinology 2015 (2015): 1–5. http://dx.doi.org/10.1155/2015/685281.
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Objective.To determine if sexual intercourse reduces absorption of vaginal progesterone gel in women and to determine if progesterone is absorbed by the male during intercourse.Study Design.Prospective, randomized, cross over, controlled study of 20 reproductive-aged women and their male sexual partners randomized to receive vaginal progesterone gel (Crinone 8% gel, Actavis Inc., USA) or placebo cream. Serum progesterone for both male and female partners were measured 10 hours after intercourse. One week later, subjects were crossed over to receive the opposite formulation. In the third week, women used progesterone gel at night and abstained from intercourse.Results.Serum progesterone was significantly reduced with vaginal progesterone gel + intercourse compared with vaginal progesterone gel + abstinence(P=0.0075). Men absorbed significant progesterone during intercourse with a female partner using vaginal progesterone gel compared to placebo(P=0.0008).Conclusion(s).Vaginal progesterone gel is reduced in women after intercourse which may decrease drug efficacy during luteal phase support. Because men absorb low levels of progesterone during intercourse, exposure could cause adverse effects such as decreased libido. This study is registered under Clinical Trial numberNCT01959464.
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Marques, Carlos Alberto Sá, Paloma de Barros Henrique, Haliny da Silva Magalhães, Tahira Souza Melo, Amouni Mohmoud Mourad, and Jan Carlo Morais Oliveira Bertassoni Delorenzi. "Vaginose bacteriana – avaliação da atividade antimicrobiana seletiva de gel de Schinus terebinthifolia raddi." Brazilian Journal of Health Review 7, no. 2 (March 26, 2024): e68360. http://dx.doi.org/10.34119/bjhrv7n2-202.
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O microbioma vaginal sofre contínua flutuação durante o ciclo menstrual e após a menopausa. Albert Döderlein foi o primeiro a descrever sobre bactérias produtoras de ácido láctico na cavidade vaginal. Tais bactérias são capazes de inibir o crescimento de microrganismos anaeróbios e patogênicos. Quando há a redução desses lactobacilos, há proliferação de bactérias oportunistas como as do gênero Gardnerella. A vaginose bacteriana (VB) é uma patologia não sexualmente transmissível, caracterizada pelo aumento do número de bactérias anaeróbias e do pH vaginal, ocasionando um corrimento vaginal acinzentado e de odor fétido. A prevalência estimada é alta, no entanto a cura efetiva e duradoura é ainda incerta. Essa falha em tratar adequadamente tem motivado a busca de alternativas terapêuticas, que consigam tratar e prevenir as possíveis recidivas da patologia1. No Brasil, a espécie Schinus terebinthifolia Raddi (aroeira-da-praia) é bem conhecida, e um ensaio clínico mostrou sua atuação de forma eficaz no tratamento da VB, bem como a recomposição da microbiota vaginal. O presente estudo tem por objetivo determinar a capacidade do gel de Schinus terebinthifolia Raddi em inibir o crescimento dos microrganismos Lactobacillus gasseri ATCC 19992 e Gardnerella vaginalis ATCC 14018. Foram usados Lactobacillus gasseri ATCC 19992 e Gardnerella vaginalis ATCC 14018. As culturas de trabalho foram produzidas com incubação a 36°±1°C por 24 horas. Foram efetuados pequenos poços nas placas com meio de cultura, onde a amostra teste foi inoculada. As placas foram incubadas por 48 horas a temperatura de 30°C. Não foi observado halo de inibição contra L. gasseri, enquanto que foi observado halo de inibição contra G. vaginalis. Tais dados, demonstram que o gel de Schinus terebinthifolia Raddi tem ação anaerobicida contra um dos principais microrganismos causadores da VB e, ao mesmo tempo, não apresenta nenhuma alteração na formação das colônias de L. gasseri, um dos lactobacilos da microbiota vaginal.
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Baloglu, Esra, Andreas Bernkop-Schnürch, Sinem Yaprak Karavana, and Zeynep Ay Senyigit. "Strategies to Prolong the Intravaginal Residence Time of Drug Delivery Systems." Journal of Pharmacy & Pharmaceutical Sciences 12, no. 3 (October 13, 2009): 312. http://dx.doi.org/10.18433/j3hp41.
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The vagina has been studied as a favorable site for local and systemic delivery of drugs for female-related conditions. There are a large number of vaginal medications on the market and most of them require frequent application due to their short vaginal residence time. A prolonged vaginal residence time of formulations is therefore a key parameter for improved therapeutic efficacy. Promising approaches to prolong the residence time base on mucoadhesion, in- situ sol-gel transition and mechanical fixation. Mucoadhesive drug delivery systems can be tailored to adhere to the vaginal tissue. In-situ gelling systems offer the advantage of increased viscosity in vaginal cavity and consequently reduce outflow from the vagina. Mechanical fixation needs specially shaped drug delivery systems and reduce the frequency of administration significantly. Within this review an overview on these different strategies and systems is provided. Furthermore, the techniques to evaluate the potential of these systems for prolonged vaginal residence time are described.
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&NA;. "Dapivirine vaginal gel well tolerated." Reactions Weekly &NA;, no. 1265 (August 2009): 3. http://dx.doi.org/10.2165/00128415-200912650-00006.
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Rochani, Ankit, Vivek Agrahari, Neelima Chandra, Onkar N. Singh, Timothy J. McCormick, Gustavo F. Doncel, Meredith R. Clark, and Gagan Kaushal. "Development and Preclinical Investigation of Physically Cross-Linked and pH-Sensitive Polymeric Gels as Potential Vaginal Contraceptives." Polymers 14, no. 9 (April 23, 2022): 1728. http://dx.doi.org/10.3390/polym14091728.
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This study explored the development of cross-linked gels to potentially provide a physical barrier to vaginal sperm transport for contraception. Two types of gels were formulated, a physically cross-linked iota-carrageenan (Ci) phenylboronic acid functionalized hydroxylpropylmethyacrylate copolymer (PBA)-based (Ci-PBA) gel, designed to block vaginal sperm transport. The second gel was pH-shifting cross-linked Ci-polyvinyl alcohol-boric acid (Ci-PVA-BA) gel, designed to modulate its properties in forming a viscoelastic, weakly cross-linked transient network (due to Ci gelling properties) on vaginal application (at acidic pH of ~3.5–4.5) to a more elastic, densely cross-linked (due to borate-diol cross-linking) gel network at basic pH of 7–8 of seminal fluid, thereby acting as a physical barrier to motile sperm. The gels were characterized for dynamic rheology, physicochemical properties, and impact on sperm functionality (motility, viability, penetration). The rheology data confirmed that the Ci-PBA gel was formed by ionic interactions whereas Ci-PVA-BA gel was chemically cross-linked and became more elastic at basic pH. Based on the screening data, lead gels were selected for in vitro sperm functionality testing. The in vitro results confirmed that the Ci-PBA and Ci-PVA-BA gels created a barrier at the sperm-gel interface, providing sperm blocking properties. For preclinical proof-of-concept, the Ci-PBA gels were applied vaginally and tested for contraceptive efficacy in rabbits, demonstrating only partial efficacy (40–60%). Overall, the in vitro and in vivo results support the development and further optimization of cross-linked gels using commercially available materials as vaginal contraceptives.
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Ahmad, Farhan, Mohd Alam, Zeenat Khan, Roop Khar, and Mushir Ali. "Development and in vitro evaluation of an acid buffering bioadhesive vaginal gel for mixed vaginal infections." Acta Pharmaceutica 58, no. 4 (December 1, 2008): 407–19. http://dx.doi.org/10.2478/v10007-008-0023-2.
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Development andin vitroevaluation of an acid buffering bioadhesive vaginal gel for mixed vaginal infectionsAn acid buffering bioadhesive vaginal (ABBV) gel was developed for the treatment of mixed vaginal infections. Different bioadhesive polymers were evaluated on the basis of their bioadhesive strength, stability and drug release properties. Bioadhesion and release studies showed that guar gum, xanthan gum and hydroxypropyl methylcelullose K4M formed a good combination of bioadhesive polymers to develop the ABBV gel. Monosodium citrate was used as an acid buffering agent to provide acidic pH (4.4). The drugs clotrimazole (antifungal) and metronidazole (antiprotozoal as well as antibacterial) were used in the formulation along withLactobacillusspores to treat mixed vaginal infections. Theex vivoretention study showed that the bioadhesive polymers hold the gel for 12-13 hours inside the vaginal tube. Results of thein vitroantimicrobial study indicated that the ABBV gel had better antimicrobial action than the commercial intravaginal drug delivery systems and retention was prolonged in anex vivoretention experiment.
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Lima, Sonia M. Rolim Rosa, Silvia Saito Yamada, Benedito Fabiano Reis, Sostenes Postigo, Maria Antonieta L. Galvão da Silva, and Tsutomu Aoki. "Effective treatment of vaginal atrophy with isoflavone vaginal gel." Maturitas 74, no. 3 (March 2013): 252–58. http://dx.doi.org/10.1016/j.maturitas.2012.11.012.
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Wain, A. M. "Metronidazole vaginal gel 0.75% (MetroGel-Vaginal�): A brief review." Infectious Diseases in Obstetrics and Gynecology 6, no. 1 (1998): 3–7. http://dx.doi.org/10.1002/(sici)1098-0997(1998)6:1<3::aid-idog2>3.0.co;2-0.
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Destache, Christopher J., Subhra Mandal, Zhe Yuan, Guobin Kang, Abhijit A. Date, Wuxun Lu, Annemarie Shibata, et al. "Topical Tenofovir Disoproxil Fumarate Nanoparticles Prevent HIV-1 Vaginal Transmission in a Humanized Mouse Model." Antimicrobial Agents and Chemotherapy 60, no. 6 (April 4, 2016): 3633–39. http://dx.doi.org/10.1128/aac.00450-16.
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Preexposure prophylaxis (PrEP) with 1% tenofovir (TFV) vaginal gel has failed in clinical trials. To improve TFV efficacy in vaginal gel, we formulated tenofovir disoproxil fumarate nanoparticles in a thermosensitive (TMS) gel (TDF-NP-TMS gel). TDF-NPs were fabricated using poly(lactic-co-glycolic acid) (PLGA) polymer and an ion-pairing agent by oil-in-water emulsification. The efficacy of TDF-NP-TMS gel was tested in humanized bone marrow-liver-thymus (hu-BLT) mice. Hu-BLT mice in the treatment group (Rx;n= 15) were administered TDF-NP-TMS gel intravaginally, having TDF at 0.1%, 0.5%, and 1% (wt/vol) concentrations, whereas the control (Ctr;n= 8) group received a blank TMS gel. All Rx mice (0.1% [n= 4], 0.5% [n= 6], and 1% [n= 5]) were vaginally challenged with two transmitted/founder (T/F) HIV-1 strains (2.5 × 10550% tissue culture infectious doses). Rx mice were challenged at 4 h (0.1%), 24 h (0.5%), and 7 days (1%) posttreatment (p.t.) and Ctr mice were challenged at 4 h p.t. Blood was drawn weekly for 4 weeks postinoculation (p.i.) for plasma viral load (pVL) using reverse transcription-quantitative PCR. Ctr mice had positive pVL within 2 weeks p.i. Rx mice challenged at 4 h and 24 h showed 100% protection and no detectable pVL throughout the 4 weeks of follow-up (P= 0.009; Mantel-Cox test). Mice challenged at 7 days were HIV-1 positive at 14 days p.i. Further, HIV-1 viral RNA (vRNA) in vaginal and spleen tissues of Rx group mice with negative pVL were examined using anin situhybridization (ISH) technique. The detection of vRNA was negative in all Rx mice studied. The present studies elucidate TDF-NP-TMS gel as a long-acting, coitus-independent HIV-1 vaginal protection modality.
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Patton, D. L., Y. T. Cosgrove Sweeney, T. D. McCarthy, and S. L. Hillier. "Preclinical Safety and Efficacy Assessments of Dendrimer-Based (SPL7013) Microbicide Gel Formulations in a Nonhuman Primate Model." Antimicrobial Agents and Chemotherapy 50, no. 5 (May 2006): 1696–700. http://dx.doi.org/10.1128/aac.50.5.1696-1700.2006.
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ABSTRACT Three gel formulations (1%, 3%, and 5% [wt/wt]) of SPL7013, a dendrimer known to have antiviral (anti-human immunodeficiency virus and anti-herpes simplex virus) activities, completed a range of preclinical tests in the pigtailed macaque models for vaginally and rectally applied topical microbicide safety assessments. The vaginal safety profile of the 3% SPL7013 gel formulation was equal to that of the 1% formulation but was superior to that of the 5% formulation. The 3% SPL7013 gel was further evaluated for rectal safety and for antichlamydial efficacy with cervical challenge with Chlamydia trachomatis. This first-generation dendrimer-based product was shown to be safe to the vaginal and rectal microenvironments with repeated daily use. However, a single intravaginal application of the 3% (wt/wt) SPL7013 gel did not provide protection from the acquisition of cervical chlamydial infection.
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Saunders, Helen, Cass Khan, Thomas D’Hooghe, Thora Björg Magnúsdóttir, Ingrid Klingmann, and Sigrún Hrafnsdóttir. "Efficacy, safety and tolerability of progesterone vaginal pessaries versus progesterone vaginal gel for luteal phase support after in vitro fertilisation: a randomised controlled trial." Human Reproduction 35, no. 2 (February 2020): 355–63. http://dx.doi.org/10.1093/humrep/dez261.
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Abstract STUDY QUESTION Are progesterone vaginal pessaries 400 mg twice a day (bid) non-inferior to progesterone vaginal gel (90 mg) once a day (od) in the primary endpoint of clinical pregnancy rate after 38 days of luteal phase support in women undergoing in vitro fertilisation (IVF)? SUMMARY ANSWER Non-inferiority of progesterone vaginal pessaries 400 mg bid to progesterone 8% vaginal gel (90 mg od) was shown for clinical pregnancy rate after 38 days of luteal phase support. WHAT IS KNOWN ALREADY To maximise successful embryo transfer after IVF, additionally administered progesterone is used for proper endometrium transformation in the luteal phase. Vaginally administered progesterone results in adequate secretory transformation of the endometrium. STUDY DESIGN, SIZE, DURATION This multicentre, multinational, open, randomised, two-parallel group, non-inferiority Phase 3 clinical trial was carried out at 17 study sites in five European countries (Belgium, Bulgaria, Czech Republic, Hungary and Serbia) between October 2013 and August 2014. An interactive web response system (IWRS) was implemented for treatment allocation at the sites. Power analysis, based on the assumptions of a non-inferiority margin of −9%, a significance level of α 2.5% (one-sided), power 90%, at a reference pregnancy rate for the progesterone vaginal gel group of 30%, as well as applying a dropout rate of 10%, yielded a total number of 766 patients to be randomised. PARTICIPANTS/MATERIALS, SETTING, METHODS Women aged between 18 and 40 years with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) and embryo transfer were eligible to participate. The clinical pregnancy rate was assessed by fetal heart movement measured by transvaginal ultrasound at day 38 (D38) (primary endpoint) and D70. Also assessed were biochemical pregnancy rate (assessed by serum β-hCG ≥25 IU/L), clinical implantation rates at D38, patient evaluation of vaginal bleeding and discharge (assessed by diary) and adverse event (AE) incidence, severity and relationship to study medication. MAIN RESULTS AND THE ROLE OF CHANCE A total of 769 female patients were randomised to progesterone 400 mg vaginal pessaries bid (n = 385, 50.1%) or progesterone 90 mg vaginal gel od (n = 384, 49.9%). Patients receiving progesterone vaginal pessaries and progesterone vaginal gel were comparable in demographics, baseline characteristics and number of retrieved oocytes. In the full analysis set (FAS; n = 369 progesterone vaginal pessaries and n = 368 progesterone vaginal gel), clinical pregnancy rates on D38 were 38.3% for progesterone vaginal pessaries and 39.9% for progesterone vaginal gel. In the per protocol analysis set (PP; n = 357 progesterone vaginal pessaries and n = 356 progesterone vaginal gel), clinical pregnancy rates on D38 were 38.1% for progesterone vaginal pessaries and 40.4% for progesterone vaginal gel. For the differences in pregnancy rates between the progesterone vaginal pessaries group and the progesterone vaginal gel, the lower limit of the 97.5% CI was −8.6 and −9.5% for the FAS and PP datasets, respectively. The original prespecified non-inferiority margin of −9% was thus met in the FAS dataset but was marginally below this in the PP dataset. However, the pregnancy rate of the comparator was higher than the anticipated rate of 30%, and a predetermined logistic regression model including treatment group, country and age group effects without interaction terms showed non-inferiority of progesterone vaginal pessaries to progesterone vaginal gel for both the FAS and PP populations, in that the lower limits of the 95% CIs were above 0.7 for both analyses. As a result of this, the relevant authorities accepted to widen the acceptable non-inferiority margin to −10%, and as such both the FAS and PP populations succeeded in showing non-inferiority. Biochemical pregnancy and clinical implantation rates were comparable for both treatments. Both treatment groups showed similar high compliance throughout the study, and the safety profiles were also comparable between the groups. Drug-related AEs occurred with frequencies of 15.1% with progesterone vaginal pessaries and 14.4% with progesterone vaginal gel. LIMITATIONS, REASONS FOR CAUTION Clinical pregnancy rate is a surrogate for the outcome of live birth rate. WIDER IMPLICATIONS OF THE FINDINGS Progesterone 400 mg pessaries bid for luteal phase support is an effective, safe and tolerable treatment option for women undergoing IVF during ART. STUDY FUNDING/COMPETING INTEREST(S) This work was funded by Actavis Group PTC ehf., Iceland, part of Teva Pharmaceuticals, and by L.D. Collins & Co. Ltd. Gedeon Richter plc has recently entered into a license and distribution agreement to commercialise the vaginal pessaries in the European Union (except Ireland/UK). The progesterone vaginal pessaries studied are now marketed as Cyclogest®, Amelgen®, Cyclovita®, Luteum and Cygest® throughout the EU, Asia and Middle East & North Africa. The competing interests are as follows. H.S.: employee of Gedeon Richter plc/PregLem S.A. C.K.: consultant to L.D. Collins & Co. Ltd and received consulting fees for work performed. T.D.H.: at the initiation and completion of this study, full professor at KU Leuven and Head of Leuven University Fertility Center at the University Hospital Gasthuisberg, Leuven, Belgium. In October 2015, T.D.H. became vice president of Global Medical Affairs Fertility at the pharmaceutical company Merck—marketing authorisation holder of the Progesterone vaginal gel (Crinone®)—and has remained a part-time professor at KU Leuven (Belgium) and adjunct professor at Yale University (New Haven, CT, USA). T.B.M.: at the initiation and completion of this study, employee of Actavis Group PTC ehf. I.K.: consultant to Actavis, later TEVA and received consulting fees for work performed. S.H.: at the initiation and completion of this study, employee of Actavis Group PTC ehf. Trial registration number EudraCT number 2013-001105-81 Trial registration date 2 July 2013 Date of first patient’s enrolment 9 October 2013
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Hiba, Salmo M. "Investigation the effect of different concentrations of carbomer & Co solvent propylene glycol on the releasing process of tinidazole from vaginal aqueous gel." Al Mustansiriyah Journal of Pharmaceutical Sciences 3, no. 1 (June 1, 2006): 75–85. http://dx.doi.org/10.32947/ajps.v3i1.411.
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The ability of local mucoadhesive vaginal aqueous gel to deliver the antibacterial, antiprotozoal tinidazole (TND) to vaginal endolayers is dependent on its releasing out of the drug from vehicle to the mucosal layer of the vagina and then exert its local effect. This depends upon the physicochemical properties of the drug, vehicle & the composition of the releasing medium used.The effect of different concentration of carbomer 941(0.5, 1&2% w/w) on the release of TND (2%w/w) from the aqueous gel base in absence & presence of various concentration of propylene glycol (PG) to the stimulant vaginal fluid (S.V.F) medium was investigated. The release of TND from low concentration of carbomer (0.5% w/w) aqueous gel base was higher & its followed fickian mechanism of the release while an anomalous mechanism holds the releasing of drug from a high concentration of carbomer (1&2% w/w) aqueous gel base, the release of TND from aqueous gel containing low concentration of PG was markedly higher than that of aqueous gel having a higher concentration of PG. The solubility of TND in different concentration of PG : water solution were alsoinvestigated. The releasing method were carried out using both S.V.F (pH4.2) & citrate buffer (pH4.2). It was found that the using of S.V.F considered to be useful for the evaluation of topically prepared vaginal dosage form as a releasing medium.Furthermore the swelling index or (swelling percent) of 1gm carbomer polymer in S.V.F was measured after 4 hours incubation of the dry polymer in the fluid. The initial rate of swelling & the swelling equilibrium of (0.5, 1&2% w/w) dry carbomer in the S.V.F were also investigated, 0.5 % w/w cabomer aqueous gel has a high rate of swelling & swelling to equilibrium size rapidly, while 1&2% w/w carbomer aqueous gel having a low rate of swelling & swelling to equilibrium size slowly.
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Ayala, Salomón, Juan Rojas, David Díaz, José Juárez, and Carlos Delgado. "Evaluación de la toxicidad vaginal de Croton lechleri en conejas." Anales de la Facultad de Medicina 71, no. 2 (May 7, 2011): 83. http://dx.doi.org/10.15381/anales.v71i2.78.
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Objetivo: Evaluar la toxicidad vaginal de una preparación en gel de Croton lechleri en conejas. Diseño: Estudio experimental. Institución: Centro de Investigación de Bioquímica y Nutrición Alberto Guzmán Barrón, Instituto de Investigaciones Clínicas, Instituto de Patología de la Facultad de Medicina, y Facultad de Farmacia, Universidad Nacional Mayor de San Marcos, Lima, Perú. Material biológico: Resina de Croton lechleri y conejos hembras, blancos, Nueva Zelanda. Métodos: Los animales fueron distribuidos en tres grupos (n=5): I. Control, vehículo; II, C. lechleri 1%; y III, C. lechleri 5%; los conejos recibieron estas muestras en un volumen de 1 mL por vía intravaginal, una vez/día, durante 10 días consecutivos. Se observó el estado clínico general, así como la apariencia física de la vagina y el perineo por signos de flujo, eritema y edema. Al final del experimento se realizó la exéresis quirúrgica de la vagina de cada coneja y se evaluó macroscópicamente, buscando signos de irritación, sangrado o daño de la mucosa. Luego, se fijó en formol tamponado al 10% y posteriormente se tomó tres muestras representativas de las regiones cérvico-vaginal, media-vaginal, y urovaginal, para el estudio histopatológico. Principales medidas de resultados: Irritación vaginal. Resultados: El examen macroscópico de la vagina en el grupo control mostró aspecto congestivo leve en forma difusa, en todos los casos, y de aspecto similar en las muestras del grupo Croton lechleri al 1%. En la formulación al 5%, en dos casos se observó congestión petequial parcial leve. El estudio histopatológico reveló un puntaje promedio de irritación vaginal de 3,4 a 6 y 3,6 a 8 para las preparaciones al 1% y 5%, respectivamente. Conclusión: En nuestras condiciones experimentales, las preparaciones de gel de C. lechleri evaluadas fueron no irritantes para la mucosa vaginal y resultaron aceptables.
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Mirzaeei, Shahla, Maryam Zangeneh, Firoozeh Veisi, Somayeh Parsa, and Maryam Hematti. "Chlorhexidine, clotrimazole, metronidazole and combination therapy in the treatment of vaginal infections." Journal of Medicine and Life 14, no. 2 (March 2021): 250–56. http://dx.doi.org/10.25122/jml-2019-0160.
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This was a clinical trial study that aimed to investigate the efficacy of vaginal chlorhexidine gel in the treatment of vulvovaginal candidiasis, bacterial vaginosis, and nonspecific vaginitis. The study population included patients who complained of vaginal discharge and presented to our University Gynecology Clinic. The data were analyzed using the Statistical Package for the Social Sciences (SPSS) software. The student t-test and Mann-Whitney U test were used to analyze the quantitative and ordinal data, respectively. In order to analyze the qualitative data, the Chi-square or Fischer’s exact tests were used. The mean satisfaction score in the vulvovaginal candidiasis patients who received chlorhexiine vaginal gel was 9.06 and 8.29 in the patients who received clotrimazole vaginal cream. The Mann-Whitney test did not show a statistically significant difference between mean scores of VAS in these two groups with vulvovaginal candidiasis (P=0.027). Among the patients with bacterial vaginosis, the mean satisfaction score was 8.91 in the chlorhexidine vaginal gel group and 8.72 in the metronidazole tablet group (P=0.607). In the nonspecific vaginitis group, the mean satisfaction score was 8.83 in the chlorhexidine vaginal gel group and 9.17 in the combination group (metronidazole + clotrimazole vaginal cream)(P=0.401). The highest mean visual analog scale score (VAS) score was documented in the combination therapy group. We found that chlorhexidine vaginal gel is a more effective method for the treatment and improvement of vaginal infections. The benefits of chlorhexidine gel have a positive therapeutic effect as a single drug in nonspecific vaginitis, rather than simultaneous administration of two agents.
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Taran, O. A., O. V. Bulavenko, D. G. Konkov, and T. V. Lobastova. "The clinical experience for optimizing the reparative processes of the cervix after destructive surgical interventions." HEALTH OF WOMAN, no. 3(139) (April 30, 2019): 38–42. http://dx.doi.org/10.15574/hw.2019.139.38.
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The objective: to evaluate the therapeutic approach in order to improve regenerate the epithelium of the cervical mucosa and restore of the vaginal biocenosis after laser vaporization in women of reproductive age with CIN I with including the vaginal gel which consist of decametoxinum and hyaluronic acid. Materials and methods. 60 women of reproductive age were examined with CIN І, confirmed by histological examination, which underwent laser vaporization. The main clinical group (n=30), for patients were prescribed 5 ml vaginal gel which consist of decametoxinum and hyaluronic acid (Ginodek®) for 7–10 days after laser vaporization with a course of 14 days. The comparison group were consisted of 30 patients who, after laser destruction of the cervix, were prescribed standard therapy. We were used colposcopy for visual inspection of the cervical reparative processes. According to the results of a microbiological study, the vaginal biocenosis was evaluated. The side effects that were associated with the use of Ginodek® vaginal gel were evaluated. Results. It was proved that the use of vaginal gel Ginodek® in patients with CIN I after laser vaporization resulted in faster and more complete epithelialization of the wound surface than the standard therapy (RR 1.56; 95% CI: 1.08–2.26; p=0.02). 2 months after the application of vaginal gel Ginodek®, we found significant increasing cases of normalization of vaginal microbiota (RR 1.44; 95% CI: 1.04–2.00; p=0.03), increase in the number of lactobacilli in the vaginal secretion (RR 1.50; 95% CI: 1.03–2.19; p=0.04) and a decrease in the number of cases of vaginal candidiasis (RR 1.27; 95% CI: 1.005–1.61; p=0.045). Not a single adverse effects on were noted when using vaginal gel Ginodek®, both during the course of therapy and at a later date. Conclusion. The obtained results were testified to the acceleration of the reparative processes of the cervix, the reduction of the microbial effect and safety when using vaginal gel Ginodek® after laser vaporization in women with CIN І. Key words: cervical neoplasia, laser vaporization, vaginal microbiota, epithelization, Ginodek®.
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Pereira, Lara E., Pedro M. M. Mesquita, Anthony Ham, Tyana Singletary, Frank Deyounks, Amy Martin, Janet McNicholl, Karen W. Buckheit, Robert W. Buckheit, and James M. Smith. "Pharmacokinetic and Pharmacodynamic Evaluation following Vaginal Application of IQB3002, a Dual-Chamber Microbicide Gel Containing the Nonnucleoside Reverse Transcriptase Inhibitor IQP-0528 in Rhesus Macaques." Antimicrobial Agents and Chemotherapy 60, no. 3 (December 14, 2015): 1393–400. http://dx.doi.org/10.1128/aac.02201-15.
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We evaluated thein vivopharmacokinetics and used a complementaryex vivococulture assay to determine the pharmacodynamics of IQB3002 gel containing 1% IQP-0528, a nonnucleoside reverse transcriptase inhibitor (NNRTI), in rhesus macaques (RM). The gel (1.5 ml) was applied vaginally to 6 simian-human immunodeficiency (SHIV)-positive female RM. Blood, vaginal fluids, and rectal fluids were collected at 0, 1, 2, and 4 h. RM were euthanized at 4 h, and vaginal, cervical, rectal, and regional lymph node tissues were harvested. Anti-human immunodeficiency virus (HIV) activity was evaluatedex vivoby coculturing fresh or frozen vaginal tissues with activated human peripheral blood mononuclear cells (PBMCs) and measuring the p24 levels for 10 days after an HIV-1Ba-Lchallenge. The median levels of IQP-0528, determined using liquid chromatography-tandem mass spectroscopy (LC-MS/MS) methods, were between 104and 105ng/g in vaginal and cervical tissue, between 103and 104ng/g in rectal tissues, and between 105and 107ng/ml in vaginal fluids over the 4-h period. The vaginal tissues protected the cocultured PBMCs from HIV-1 infectionex vivo, with a viral inhibition range of 81 to 100% in fresh and frozen tissues that were proximal, medial, and distal relative to the cervix. No viral inhibition was detected in untreated baseline tissues. Collectively, the median drug levels observed were 5 to 7 logs higher than thein vitro50% effective concentration (EC50) range (0.21 ng/ml to 1.29 ng/ml), suggesting that 1.5 ml of the gel delivers IQP-0528 throughout the RM vaginal compartment at levels that are highly inhibitory to HIV-1. Importantly, antiviral activity was observed in both fresh and frozen vaginal tissues, broadening the scope of theex vivococulture model for future NNRTI efficacy studies.
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Chougala, Ashwini, and Arati Mahishale. "A Randomized Clinical Trial to evaluate the Effect of Therapeutic Ultrasound and Low-level Laser Therapy on Perineal Pain following Vaginal Delivery with Episiotomy." Journal of South Asian Federation of Obstetrics and Gynaecology 7, no. 3 (2015): 152–56. http://dx.doi.org/10.5005/jp-journals-10006-1346.
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ABSTRACT Background and objectives Vaginal delivery has an enormous amount of pressure on the perineum, the area between vagina and anus, which must stretch to accommodate the baby's head during its passage through the birth canal. During childbirth, the perineum may tear or the obstetrician may decide to incise to make wider opening for baby's head to pass, a procedure called as episiotomy. The area of episiotomy may be uncomfortable and painful for several days. The present study aimed to evaluate the effect of therapeutic ultrasound and low-level laser therapy (LLLT) on perineal pain following vaginal delivery with episiotomy. Materials and methods Sixty women, who underwent vaginal delivery with episiotomy, complaining of perineal pain were recruited and randomly allocated to two treatment groups. Physiotherapy intervention included cryo gel pad and therapeutic ultrasound in group A and cryo gel pad and lowlevel laser therapy in group B once daily for 3 consecutive days. Outcomes Measures were documented using visual analog scale (VAS) for pain and REEDA scale (redness, edema, ecchymosis, discharge, approximation) for healing on 1st day preintervention and 3rd day postintervention respectively. Results The study results showed that there was statistically significant improvement postintervention in both the groups with p < 0.05, although therapeutic ultrasound with cryo gel pad showed better reduction in pain score and healing process as compared to low-level laser therapy. Conclusion Therapeutic ultrasound with cryo gel pad can be used to reduce perineal pain following vaginal delivery with episiotomy. How to cite this article Chougala A, Mahishale A. A Randomized Clinical Trial to evaluate the Effect of Therapeutic Ultrasound and Low-level Laser Therapy on Perineal Pain following Vaginal Delivery with Episiotomy. J South Asian Feder Obst Gynae 2015;7(3):152-156.
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Kalpana, Priya Sharma, Amit Kaushik, Priyanka Rao, Neelam Swaroop, and Neetu Singh. "A comparative study of low dose vaginal misoprostol and dinoprostone gel for induction of labour at term of pregnancy." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 6, no. 1 (December 20, 2016): 207. http://dx.doi.org/10.18203/2320-1770.ijrcog20164659.
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Background: The aim of this study was to compare the low dose of vaginal misoprostol and dinoprostone gel for the induction of labour at term of pregnancy.Methods: The study was conducted on 90 women, randomized into two groups, each group having 45 women. First group received misoprostol per vaginally and second group received the dinoprostone gel. The duration of induction to delivery interval, mode of delivery and complications related to labour or foetus were recorded.Results: The mean induction to delivery interval in the misoprostol group was 11.68 ± 4.49 hours and in the dioprostone gel group was 14.85 ± 7.08 hours. Applying the modified t-test, this difference is statistically significant (P value 0.004). Thus misoprostol leads to early labour and early delivery as compared to dinoprostone gel.Conclusions: As shown in this study, vaginal misoprostol is highly effective induction agent with no adverse effect on the outcome of labour as compared to dinoprostone gel.
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Zaychenko, Ganna, Olena Stryga, Oksana Sinitsyna, Anna Doroshenko, Oksana Sulaieva, Tetyana Falalyeyeva, and Nazarii Kobyliak. "Resveratrol Effects on the Reproductive System in Ovariectomized Rats: Deciphering Possible Mechanisms." Molecules 27, no. 15 (August 2, 2022): 4916. http://dx.doi.org/10.3390/molecules27154916.
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Phytoestrogen resveratrol (R) has been demonstrated to benefit human reproductive health. However, R bioavailability and pharmacokinetics are still problematic under oral supplementation. We used an experimental vaginal gel with R and hyaluronic acid (HA) to improve bioavailability and pharmacokinetic properties. The study aimed to assess the impact of vaginal R-HA gel on the reproductive system in ovariectomized rats. Methods: The study was carried out on Wistar female rats. It investigated the body weight, tail temperature, vaginal pH, estrogen and progesterone blood levels, and immunohistochemical biomarkers (COX2, Casp-3, Bcl-2, and VEGF). Animals were divided into control animals; ovariectomized rats (OVX); and OVX group treated with vaginal 0.5% R-HA gel (0.5%, 0.1 mL, daily 28 days). Results: The R-HA gel’s therapeutic effect was manifested by slowing weight gain by 17% (p < 0.001), less pronounced symptom of fever at the root of the tail by 9% (p < 0.001) and lowering the vaginal pH to 4.4–4.5 compared with OVX rats. The anti-inflammatory effect and the reduction of COX-2 expression in vagina were accompanied by antiapoptotic impact of RA-H on endometrium, associated with the decreased Casp-3 expression (p < 0.001) and elevated Bcl-2 score in endometrial glands (p = 0.01). Together with enhanced VEGF expression in endometrial glands (p < 0.001) and stromal cells (p = 0.007), these changes prevented endometrial atrophy (p < 0.001) after ovariectomy. Thus, this study substantiates the feasibility of developing an innovative topical drug with R and HA for treating hypoestrogenic disorders.
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Md, Tanweer A. Syed, A. Qureshi, Seyed Ali Ahmad, and Shahida M. Ali. "Management of intravaginal warts in women with 5-fluorouracil (1%) in vaginal hydrophilic gel: a placebo-controlled double-blind study." International Journal of STD & AIDS 11, no. 6 (June 1, 2000): 371–74. http://dx.doi.org/10.1258/0956462001916074.
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The purpose of this placebo-controlled, double-blind study was to determine the safety, tolerability and clinical efficacy of 5-fluorouracil (1%) in a vaginal hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal papillomas in women. Pre-selected, 60 women ranging between 18 and 50 years of age (mean 24.6), having 312 vaginal condylomas (mean 5.2) joined the study. The diagnosis of human papillomavirus (HPV) was established with clinical, histopathological and polymerase chain reaction (PCR) techniques. Subjects were randomized into 2 parallel groups. Each patient was allocated a pre-coded tube 15 g (active or placebo) with graduated vaginal applicators (disposable), and instructions how to insert 4 g of the trial medication deep into the vagina once at bedtime on every other day (1, 3 and 5) per week, to visit the clinic on day 7 for clinical evaluations and to receive the same pre-coded replacement to continue the regimen for another week. A maximum 12 applications were to be used in 4 weeks. Cure was defined as absence of clinical signs of infection, re-confirmed by PCR and Southern blot hybridization negative HPV DNA. By the end of the treatment 48.4% patients and 51.9% lesions were cured. Breaking the code revealed that 5-fluorouracil (1%) gel had cured 83.3% patients and 87% intravaginal warts. Placebo resolved 13.3% patients and 14% condylomas; (active gel versus placebo; P < 0.001). Twelve patients (20%) mostly in the active gel experienced mild erythema, erosion and oedema, with no drop-outs. Among cured patients 3 had a relapse after 16 months. In conclusion, the clinical results of the study demonstrate that 5-fluorouracil (1%) in a vaginal hydrophilic gel is safe, tolerable and significantly more effective than placebo to cure intravaginal warts in women.
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Andrade, Ana Ochoa, María Emma Parente, and Gastón Ares. "Screening of mucoadhesive vaginal gel formulations." Brazilian Journal of Pharmaceutical Sciences 50, no. 4 (December 2014): 931–41. http://dx.doi.org/10.1590/s1984-82502014000400029.
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Rational design of vaginal drug delivery formulations requires special attention to vehicle properties that optimize vaginal coating and retention. The aim of the present work was to perform a screening of mucoadhesive vaginal gels formulated with carbomer or carrageenan in binary combination with a second polymer (carbomer, guar or xanthan gum). The gels were characterised using in vitroadhesion, spreadability and leakage potential studies, as well as rheological measurements (stress and frequency sweep tests) and the effect of dilution with simulated vaginal fluid (SVF) on spreadability. Results were analysed using analysis of variance and multiple factor analysis. The combination of polymers enhanced adhesion of both primary gelling agents, carbomer and carrageenan. From the rheological point of view all formulations presented a similar behaviour, prevalently elastic and characterised by loss tangent values well below 1. No correlation between rheological and adhesion behaviour was found. Carbomer and carrageenan gels containing the highest percentage of xanthan gum displayed good in vitro mucoadhesion and spreadability, minimal leakage potential and high resistance to dilution. The positive results obtained with carrageenan-xanthan gum-based gels can encourage the use of natural biocompatible adjuvants in the composition of vaginal products, a formulation field that is currently under the synthetic domain.
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Kong, Lin, Jie Kong, Zhihong Chai, GuoXian Tao, Xianli Cai, Lingxiao Ying, and Jinmei Shi. "Recombinant Interferon α-2B Gel Combined with Lactobacillus as a Vaginal Capsule in Patients with Cervical High-Risk Human Papillomavirus." Current Topics in Nutraceutical Research 21, no. 1 (October 26, 2022): 47–52. http://dx.doi.org/10.37290/ctnr2641-452x.21:47-52.
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This study was performed to investigate the effects of Lactobacillus vaginal capsules combined with recombinant human interferon α-2b gel on clinical efficacy, vaginal microbial function indicators, vaginal microecological balance, inflammation levels, and drug safety in patients with persistent cervical high-risk human papillomavirus infection. Patients with human papillomavirus infection (n = 128) were randomly divided into control and observation groups of equal size. Patients in the control group were treated with recombinant human interferon α-2b gel alone. Patients in the observation group were treated with Lactobacillus vaginal capsules and human interferon α-2b gel. After treatment, the clinical efficiency, microbial function index, and human papillomavirus-DNA conversion rate of patients in the observation group were significantly higher than those in the control group. Further, pH, Nugent scores, human papillomavirus-DNA viral load, vaginal microecological dysregulation rate, and inflammation level were significantly lower than those in the control group. Lactobacillus vaginal capsules in combination with recombinant human interferon α-2b gel improved clinical outcomes and disease regression rates in patients with human papillomavirus infection, while also improving vaginal microecological balance and suppressing inflammatory responses.
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Wain, A. M. "Metronidazole Vaginal Gel 0.75% (MetroGel-Vaginal®): A Brief Review." Infectious Diseases in Obstetrics and Gynecology 6, no. 1 (1998): 3–7. http://dx.doi.org/10.1155/s1064744998000027.
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Sukhanova, A. A., V. V. Sumenko, and R. R. Tkachuk. "Alternative possibilities of hyaluronic acid in genitourinary symptoms treatment." REPRODUCTIVE ENDOCRINOLOGY, no. 59 (July 22, 2021): 92–100. http://dx.doi.org/10.18370/2309-4117.2021.59.92-100.
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Research objective: to evaluate the clinical efficacy of vaginal gel with hyaluronic acid Revitaxa gel in comparison with synthetic estrogen-like topical agent in the treatment of women with genitourinary syndrome, to determine the recurrence rate of atrophic changes as a result of these schemes.Materials and methods. The study included 60 women with genitourinary manifestations and atrophic changes of the vaginal mucosa and cervical epithelium. Clinical, cytological and colposcopic studies were performed to analyze the vaginal epithelium, vaginal microbiocenosis and vaginal tissues. All women with an inflammatory type of smear were prescribed vaginal rehabilitation before the study. Repeated laboratory examination after anti-inflammatory, antibacterial topical therapy confirmed no pathogenic microflora, but signs of atrophy persisted in all women. All women are prescribed local treatment to improve the reparative processes of the vaginal mucosa. The main group (30 women) used Revitaxa gel for local therapy; the control group (30 women) used vaginal suppositories with the synthetic estrogen-like agent promestrienum.Results. Cytological remission after treatment was observed in all women of the control group and in 76.7% of patients in the main group. Restoration of the vaginal mucosa was detected in all patients of the control group and in 90% of patients in the main group. Repeated examinations 4 months after the end of therapy determined no recurrence of atrophic colpitis in 53.3% of patients in the main group and in 30% of women in the control group. Preservation of a favorable estatrophic type of smears was observed in 43.3% of women of group I and 13.3% of patients of group II (p <0.05), which indicates a more stable effect of hyaluronic acid compared with estrogen-like agent.Conclusions. Vaginal gel with hyaluronic acid Revitaxa gel in women with genitourinary syndrome gives results similar to the synthetic estrogen-like drug with promestrienum for topical treatment according to colposcopy, cytology, hormonal colpocytology and clinical indicators. Therefore, Revitaxa gel may be recommended for effective use in women with atrophic colpitis who refuse or have contraindications for topical hormonal agents.
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Powar, P. V., and K. Kanade. "FORMULATION AND IN VITRO EVALUATION OF GEL BASED POLYHERBAL VAGINAL WASH." INDIAN DRUGS 55, no. 08 (August 28, 2018): 25–30. http://dx.doi.org/10.53879/id.55.08.10696.
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Vaginal Infection is quite common in India, a multi-city study estimated that more than 90% of women between the ages 25 and 35 suffer with vaginal infection and 93% do not follow the best personal hygiene practices. The vaginal yeast infection is caused by Candida albicans. Which is characterized by Itching, irritation in tissues at the vaginal opening (vulva), burning sensation, redness /swelling of the vulva, vaginal pain ,soreness, vaginal rash, watery vaginal discharge . The objective of the present study was to develop poly-herbal vaginal wash for prevention of Candida albicans infection. Aqueous extracts of Azadirachtaindica leaf, Ocimum Sanctum leaf and Sapindus emarginatus were formulated in an aqueous based carbopol-940 (1%w/w) gel system. Prepared poly herbal vaginal wash formulation was evaluated for their physicochemical properties like texture evaluation, pH determination, viscosity and in vitro Antifungal activity were determined along with short term stability studies. The formulated gel based poly-herbal vaginal wash had acceptable physical parameters that showed that they were compatible and in addition to this, these formulations passed the short-term stability studies. The in vitro antifungal activity studies showed that the formulated gel based vaginal wash showed significantly strong activity against C. albicans. Thus, the present study concludes that the formulated herbal vaginal wash is efficient antifungal formulations for the C. albicans vaginal infection.
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Barnable, Patrick, Giulia Calenda, Thierry Bonnaire, Radhika Menon, Keith Levendosky, Agegnehu Gettie, James Blanchard, et al. "MIV-150/Zinc Acetate Gel Inhibits Cell-Associated Simian-Human Immunodeficiency Virus Reverse Transcriptase Infection in a Macaque Vaginal Explant Model." Antimicrobial Agents and Chemotherapy 59, no. 7 (April 13, 2015): 3829–37. http://dx.doi.org/10.1128/aac.00073-15.
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ABSTRACTThe transmission of both cell-free and cell-associated immunodeficiency viruses has been demonstrated directly in multiple animal species and possibly occurs in humans, as suggested by genotyping of the infecting human immunodeficiency virus (HIV) in acutely infected women and in semen from their partners. Therefore, a microbicide may need to block both mechanisms of HIV transmission to achieve maximum efficacy. To date, most of the preclinical evaluation of candidate microbicides has been performed using cell-free HIV. New models of mucosal transmission of cell-associated HIV are needed to evaluate candidate microbicide performance. The MIV-150/zinc acetate/carrageenan (MZC) gel protects Depo-Provera-treated macaques against cell-free simian-human immunodeficiency virus reverse transcriptase (SHIV-RT) infection when applied vaginally up to 8 h before challenge. We recently demonstrated the potent activity of MZC gel against cell-free SHIV-RT in macaque vaginal explants. In the current study, we established a cell-associated SHIV-RT infection model of macaque vaginal tissues and tested the activity of MZC gel in this model. MZC gel protected tissues against cell-associated SHIV-RT infection when present at the time of viral exposure or when applied up to 4 days prior to viral challenge. These data support clinical testing of the MZC gel. Overall, ourex vivomodel of cell-associated SHIV-RT infection in macaque vaginal mucosa complements the cell-free infection models, providing tools for prioritization of products that block both modes of HIV transmission.
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Boregowda, Sateesha S., Sadanand R. Maggidi, Rajamma A. Jayaramu, Nethravathi Puttegowda, and Nikhat Parbin. "Development of an In situ Gel Polymer Composite for Local and Sustained Delivery of Drugs in Vaginal Cavity." Drug Delivery Letters 9, no. 3 (August 20, 2019): 211–21. http://dx.doi.org/10.2174/2210303109666190226152857.
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Objective: The present research work is aimed at the development of an in situ gel polymer composite to provide local and sustained delivery of therapeutic agents in the vaginal cavity. Administration of medicated gel into a vaginal cavity is very complicated, inconvenient and needs expert assistance. There is a chance of expulsion of liquid formulation from site of application, leads to poor therapeutic efficacy. The effective drug delivery system for the vaginal cavity should be of liquid for application and gel to reside in the cavity. Methods: In situ gel composed of chitosan (0.8%) cross-linked with β-glycerol phosphate (15%) and glutaraldehyde treated guar gum (0.2%) was developed. Gel was characterized for in situ gelling properties. In vitro drug release pattern of the gel was tested on a nutrient agar medium containing attenuated E. coli and B. Subtilis. In vitro diffusion pattern of gel was tested using KC-diffusion cell with Simulated Vaginal Fluid (SVF) (pH 4.2) as the diffusion medium. Results: In situ gel exhibited sharpest sol-gel transition at 35±2°C, at pH 5.4 in 62±1.31sec. The viscosity of polymer composite is 51.25±3.68 CPs at 20±2°C and 328.56±4.16 CPs at 35±2°C. The gelation time of gel was found to be decreasing as the concentration of cross-linking agent β-GP increased. Formulations exhibited a shear thinning property. Drug release from this polymeric composite was found to be highly linear and follows non-fickian diffusion mechanism. Conclusion: This advanced thermosensitive in situ gel is convenient to apply and reside in the vaginal cavity for a prolonged period of time. The gel is mucoadhesive, biodegradable and suitable for controlled drug delivery in the cavity.
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T. Tawfeeq, Alaa, Muayad S. Abbood, and Mufeda A. Jwad. "The Comparison Between The Effect of Different Medical Drugs used To Improve Endometrial Receptivity in patients with Thin Poorly Vascularized Endometrium." IraQi Journal of Embryos and Infertility Researches 13, no. 2 (November 8, 2023): 99–115. http://dx.doi.org/10.28969/ijeir.v13.i2.r8.23.
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In a perfect world, the peak of receptivity of the endometrial lining would occur simultaneously with the entry into the uterine cavity of a healthy blastocyst, which would then be able to adhere, attach, invade, and develop protected until the time of delivery. This would be the ideal scenario. The study was carried out on 200 infertile women who have thin , poorly vascularized endometrium, those patients were divided into five groups ; 40 patients in each group, group A received esterofem oral, group B received vagifem vaginal tablets, group C received sildenafil citrate gel, group D received pentoxifylline oral and group E received 4 grams of pentoxifylline vaginal gel. The endometrial thickness, vascularity zones, sub endometrial flow, and both uterine arteries resistance and pulsatility indices were assessed at the middle of the menstrual cycle (day 11–14) on a monthly basis for six cycles or until a positive pregnancy test was obtained. Pentoxifylline vaginal gel, pentoxifylline+ vitamin E capsule, and sildenafil vaginal gel have improved the vascularity indeces of endometrium and uterine arteries, while the vagifem and esterofem were less effective in terms of improving the vascularity indeces of endometrium and uterine arteries. The study also showed that 57.5% of women succeed to get pregnant after six months of receiving pentoxifylline vaginal gel, 35% of women succeed to get pregnant after six months of Pentoxifylline+vit E, while 22.5% of women succeed to get pregnant after six months of sildenafil, about 10% of women got pregnant after six months of vagifem, and finally 2.5% of women got pregnant after six months of receiving estrofem tablets. It was discovered that pentoxifylline vaginal gel, pentoxifylline tablet plus vitamin E capsule, and sildenafil vaginal gel were able to improve the vascularity index of the endometrium, the uterine arteries and endometrial thickness, and enhance the pregnancy rates in patients with thin poorly vascularized endometrium
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ZOLER, MITCHEL L. "Tenofovir Vaginal Gel Delivers HIV Prevention." Internal Medicine News 43, no. 13 (August 2010): 8–9. http://dx.doi.org/10.1016/s1097-8690(10)70662-4.
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ZOLER, MITCHEL L. "Tenofovir Vaginal Gel Blocked HIV Transmission." Family Practice News 40, no. 14 (September 2010): 30. http://dx.doi.org/10.1016/s0300-7073(10)70900-2.
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Jodar, Aaron, Luis Soto, Eva Turell, and Javier Cortés. "Monotherapy With a Non-Hormonal Centella Asiatica, Hyaluronic Acid, and Prebiotic-Based Vaginal Gel in Women With Bacterial Vaginosis: Case Series." Clinical Medicine Insights: Case Reports 16 (January 2023): 117954762311572. http://dx.doi.org/10.1177/11795476231157244.
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Bacterial vaginosis (BV) affects nearly one-third of women worldwide and may predispose patients to sexually transmitted infections or pelvic inflammatory disease. Currently recommended treatment is based on antibiotic use, which poses problems such as antibiotic resistance and the development of secondary vaginal candidiasis. Palomacare® is a non-hormonal vaginal gel containing hyaluronic acid, Centella asiatica and prebiotics, with repairing and moisturizing properties used for dysbiosis healing as an adjuvant treatment. A series of 3 cases using the vaginal gel as a monotherapy showed that symptoms improved and even disappeared in women with initial or recurrent BV, suggesting that this vaginal gel is effective for BV monotherapy in women of reproductive age.
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Saleem, Faiqa, Munazza Malik, Muhammad Sohaib Shahid, and Muhammad Tayyab. "BACTERIAL VAGINOSIS;." Professional Medical Journal 24, no. 02 (February 14, 2017): 252–57. http://dx.doi.org/10.29309/tpmj/2017.24.02.520.
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In women of reproductive age bacterial vaginosis is a most common polymicrobialdisease and is the leading reason for vaginal discharge in this age group. Additionally itis further linked with sizeable disease burden of community problem in terms of infectiouscomplications. Clindamycin vaginal cream and metronidazole vaginal gel are effective in themanagement of vaginal infections caused by multi bacteria. Objectives: To compare thetherapeutic efficacy of Metronidazole vaginal gel and clindamycin vaginal cream as modality oftreatment for bacterial vaginosis. Study Design: Randomized control trial. Setting: Departmentof Obstetrics and Gynaecology, Unit-3 Jinnah Hospital Lahore. Period: Six months from 02-05-2011 to 01-11-2011. Material & Methods: A total of 300 patients were included in this study.They were divided into two groups. Group A received metronidazole vaginal gel (5 g dailyfor 7 days) while group B administered with clindamycin vaginal cream (5g daily for 7 days).Results: Mean age of the patient was observed 34.3+3.5 and 32.9+ 2.1 years in group –A andB respectively. Vaginal discharge was absent in 104 patients (69.3%) from group A and 127(84.7%) from group-B. Absence of clue cells on microscopy revealed in 112 patients (74.7%)from group A and 137 patients (91.3%) from group B. Absence of amine odour found in 116patients (77.3%) of group A and 134 patients (89.3%) of group B. Significant difference wasfound between two groups with p value of 0.006 in respect of efficacy. Conclusion: Clindamycinvaginal cream is more effective in comparison to Metronidazole vaginal gel for the treatment ofbacterial vaginosis.
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Nuttall, Jeremy, Angela Kashuba, Ruili Wang, Nicole White, Philip Allen, Jeffrey Roberts, and Joseph Romano. "Pharmacokinetics of Tenofovir following Intravaginal and Intrarectal Administration of Tenofovir Gel to Rhesus Macaques." Antimicrobial Agents and Chemotherapy 56, no. 1 (October 10, 2011): 103–9. http://dx.doi.org/10.1128/aac.00597-11.
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ABSTRACTTenofovir gel (1%) is being developed as a microbicide for the prevention of human immunodeficiency virus (HIV) infection and has been shown to reduce transmission to women by 39%. The gel also prevents infection in macaques when applied intravaginally or intrarectally prior to challenge with simian-human immunodeficiency virus (SHIV), but very little pharmacokinetic information for macaques is available to help extrapolate the data to humans and thus inform future development activities. We have determined the pharmacokinetics of tenofovir in macaques following intravaginal and intrarectal administration of 0.2, 1, and 5% gels. Plasma and vaginal and rectal fluid samples were collected up to 24 h after dosing, and at 24 h postdosing biopsy specimens were taken from the vaginal wall, cervix, and rectum. Following vaginal and rectal administration, tenofovir rapidly distributed to the matrices distal to the site of administration. In all matrices, exposure increased with increasing dose, and with the 1% and 5% formulations, concentrations remained detectable in most animals 24 h after dosing. At all doses, concentrations at the dosing site were typically 1 to 2 log units higher than those in the opposite compartment and 4 to 5 log units higher than those in plasma. Exposure in vaginal fluid after vaginal dosing was 58 to 82% lower than that in rectal fluid after rectal dosing, but plasma exposure was 1- to 2-fold greater after vaginal dosing than after rectal dosing. These data suggest that a tenofovir-based microbicide may have the potential to protect when exposure is via vaginal or anal intercourse, regardless of whether the microbicide is applied vaginally or rectally.
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Lapina, Irina A., Julia E. Dobrokhotova, Vladislav V. Taranov, and Tatiana G. Chirvon. "Prevention of dysbiotic and inflammatory diseases of the vagina and vulva after surgical correction of genital prolapse and stress urinary incontinence." Gynecology 22, no. 6 (December 24, 2020): 111–14. http://dx.doi.org/10.26442/20795696.2020.6.200547.
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Normal vaginal microflora consists of a wide range of microorganisms that maintain optimal vaginal milieu, preventing the development of infectious and inflammatory diseases of the vulva and vagina. However, the use of drugs, changes in hormonal status, urinary incontinence and pelvic floor dysfunction can disrupt the optimal balance of the vaginal microbiota, which leads to the development of dysbiotic pathological processes. The first-line treatment for stress urinary incontinence is the installation of suburethral slings. If incontinence is combined with a cystocele, it is advisable to perform reconstructive surgery for anterior vaginal wall, which has high both anatomical and functional efficacy. Surgical correction of genital prolapse and stress urinary incontinence requires bladder catheterization, which further increases the risk for dysbiotic and inflammatory diseases of the urogenital tract. The widespread use of antibiotic therapy leads to the formation of resistant strains of microorganisms and is not always fully realized, especially in the presence of post void residual urine in the postoperative period. Vaginal Zalain suppositories are highly sensitive to Candida species, and the use of Zalagel Intim gel is associated not only with antifungal, but also anti-inflammatory effect. Complex therapy with Zalain suppositories and Zalagel Intim gel is highly effective in the treatment of cytolytic, bacterial vaginosis, vulvovaginal candidiasis, and can also be used as the prevention of infectious complications after corrective interventions for pelvic organ prolapse and stress urinary incontinence.