Clinical trials: BACTERIAL VAGINOSIS
Bacterial Vaginosis
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
This is a multicenter, randomized, double-blind, placebo-controlled study of DARE-BV1 (clindamycin phosphate vaginal gel, 2%) (QD x 1 day) compared to placebo vaginal gel (HEC Universal Placebo Gel) (QD × 1 day) for the treatment…
- Trial name
- NCT04370548
- Testing
- DARE-BV1clindamycin phosphate vaginal gel, 2%
- Where
- 10 sites in United States
- Volunteers
- 307 people
- Sponsor
- Daré Bioscience, Inc.
Bacterial Vaginosis
Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.
- Trial name
- Nefertiti (NCT04640922)
- Testing
- Gedea Pessary pHyph
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 152 people
- Sponsor
- Gedea Biotech AB
Bacterial Vaginosis
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0.
- Trial name
- NCT05211921
- Testing
- Multi-Gyn ActiGel Plus
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Karo Pharma AB
Vaginal Health
Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United…
- Trial name
- NCT05330091
- Testing
- Once Daily Women's Probiotic
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Garden of Life, LLC
Bacterial Vaginosis
A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G.
- Trial name
- NCT05060029
- Testing
- Lactobacillus Species
- Where
- 5 sites in India
- Volunteers
- 75 people
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Bacterial Vaginosis
Pharmacokinetic Study of DARE-BV1
Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV).
- Trial name
- NCT05354050
- Testing
- DARE-BV1
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Vaginosis, Bacterial
Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)
It aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).
- Trial name
- CEBAM (NCT04989543)
- Testing
- vaginal swabs
- Where
- France
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Larena SAS
Bacterial Vaginosis
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.
- Trial name
- NCT02418845
- Testing
- SYM-1219
- Where
- 21 sites in United States
- Volunteers
- 189 people
- Sponsor
- Symbiomix Therapeutics
Bacterial Vaginosis
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
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.
- Trial name
- NCT02452866
- Testing
- SYM-1219
- Where
- 40 sites in United States
- Volunteers
- 325 people
- Sponsor
- Symbiomix Therapeutics
Bacterial Vaginoses
Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV
A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosec™ (Secnidazole) in adolescent girls with BV
- Trial name
- NCT03937869
- Testing
- Secnidazole
- Where
- 9 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Lupin Research Inc
Bacterial Vaginosis
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
- Trial name
- NCT02147899
- Testing
- SYM-1219
- Where
- 16 sites in United States
- Volunteers
- 215 people
- Sponsor
- Symbiomix Therapeutics
Bacterial Vaginosis
Safety Study of Lactobacillus Administered Vaginally to Healthy Women
The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in…
- Trial name
- NCT00537576
- Testing
- Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator, High dose LACTIN-V applicator
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Osel, Inc.
Bacterial Vaginosis
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.
- Trial name
- NCT03116789
- Testing
- probiotics
- Where
- Taiwan
- Volunteers
- 43 people
- Sponsor
- GenMont Biotech Incorporation
Trichomonal Vaginitis, Bacterial Vaginosis
Evaluation of Efficacy and Safety of Gynomax® XL Ovule
Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, single-arm, multicentral study.
- Conditions
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections
- Trial name
- Gyno-Türk (NCT03839875)
- Testing
- Gynomax® XL Vaginal Ovule
- Where
- Turkey (Türkiye)
- Volunteers
- 116 people
- Sponsor
- Exeltis Turkey
BACTERIAL VAGINOSIS, Signs and Symptoms to be Evaluated and Recorded Include
A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and…
- Conditions
- BACTERIAL VAGINOSIS, Signs and Symptoms to be Evaluated and Recorded Include, Vaginal Discharge Color, Odor, and Consistency, Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe
- Trial name
- NCT02210689
- Testing
- clindamycin phosphate vaginal cream 2%
- Where
- 18 sites in United States, Dominican Republic and 1 more
- Volunteers
- 604 people
- Sponsor
- Actavis Inc.
Bacterial Vaginosis
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than…
- Trial name
- NCT03091777
- Testing
- GDC-229, Metronidazole Vaginal Gel 0.75%
- Where
- United States
- Volunteers
- 871 people
- Sponsor
- Balmoral Medical company
Candidiasis, Vaginosis, Bacterial
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference…
- Trial name
- DOBO (NCT02860845)
- Testing
- Boric acid and probiotics, Antibiotic (Clindamycin), Antifungal (Clotrimazole)
- Where
- Spain
- Volunteers
- 48 people
- Sponsor
- Laboratorios Ordesa
Bacterial Vaginosis
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
- Trial name
- NCT02237950
- Testing
- Metronidazole oral tablets 500mg, 1% SPL7013 Gel
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 586 people
- Sponsor
- Starpharma Pty Ltd
Bacterial Vaginosis
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).
- Trial name
- NCT01577238
- Testing
- 1% SPL7013 Gel
- Volunteers
- 250 people
- Sponsor
- Starpharma Pty Ltd
Bacterial Vaginosis
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).
- Trial name
- NCT01577537
- Testing
- 1% SPL7013 Gel
- Volunteers
- 251 people
- Sponsor
- Starpharma Pty Ltd