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Bacterial Vaginosis clinical trials

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NCT ID: NCT02905890 Completed - HIV Clinical Trials

The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis

HCBV
Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal inflammation.

NCT ID: NCT02866227 Completed - Bacterial Vaginosis Clinical Trials

TOL-463 Phase 2 Study for Vaginitis

Start date: July 15, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.

NCT ID: NCT02863536 Completed - Bacterial Vaginosis Clinical Trials

A Study of the New Medical Device Polybactum®

POLARIS
Start date: September 8, 2016
Phase: N/A
Study type: Interventional

The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study. Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients

NCT ID: NCT02766023 Completed - Bacterial Vaginosis Clinical Trials

LACTIN-V Study for Recurrent Bacterial Vaginosis

Start date: June 3, 2016
Phase: Phase 2
Study type: Interventional

This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.

NCT ID: NCT02744638 Completed - Bacterial Vaginosis Clinical Trials

Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.

NCT ID: NCT02709005 Completed - Bacterial Vaginosis Clinical Trials

Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

Start date: April 14, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.

NCT ID: NCT02527941 Completed - HIV Infections Clinical Trials

Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology

Start date: August 2015
Phase: Phase 1
Study type: Interventional

A non-randomized, interventional, longitudinal clinical study to quantify the impact of bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.

NCT ID: NCT02459665 Completed - Bacterial Vaginosis Clinical Trials

Rwanda Vaginal Microbiota Restoration Study

VMB
Start date: June 5, 2015
Phase: N/A
Study type: Interventional

A pilot randomized controlled clinical trial of intermittent use of two different vaginal lactobacilli-containing probiotics, and oral metronidazole, to prevent bacterial vaginosis recurrence.

NCT ID: NCT02452866 Completed - Bacterial Vaginosis Clinical Trials

Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

NCT ID: NCT02445989 Completed - HIV Clinical Trials

Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

Start date: May 2016
Phase: Phase 4
Study type: Interventional

The investigators propose to explore the hypothesis—supported by limited data—that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health. The investigators propose that this CVR will increase the bacteria that help the vaginal environment protect against infection by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the quantity of HIV that is shed in the female genital tract.