6 completed, 4 unknown, 2 not yet recruiting, 2 withdrawn. 17 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 17 | Completed 6, Unknown 4, Not yet recruiting 2, Withdrawn 2, Active not recruiting 1, Recruiting 1, Terminated 1 |
| Phase 2 | 3 | Completed 1, Terminated 1, Unknown 1 |
Follow Bacterial Vaginosis: new trials by email Literature Review of Bacterial Vaginosis trials Research Report on Bacterial Vaginosis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo, metronidazole (MTZ)+ LCFA-01 + LC103 placebo, metronidazole (MTZ)+ LC103 + LCFA-01 placebo - Bacterial Vaginosis | Phase 1 | Not yet recruiting | Massachusetts General Hospital | 280 | 2027-02-03 | 2026-10-15 |
| A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV) GenSci142 capsule, clindamycin phosphate vaginal cream - Randomized, Open-label | Phase 1 | Recruiting | Changchun GeneScience Pharmaceutical Co., Ltd. | 42 | 2026-08-15 | 2026-10-15 |
| A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women GenSci142, Placebo GenSci142 - Bacterial Vaginosis | Phase 1 | Not yet recruiting | Changchun GeneScience Pharmaceutical Co., Ltd. | 30 | 2025-12-01 | 2025-12-24 |
| Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection BGY-1601-VT, PLACEBO - Bacterial Vaginosis, Vulvovaginal Candidiasis | Phase 1 / Phase 2 | Unknown | NEXBIOME THERAPEUTICS | 165 | 2024-07-08 | 2024-06-12 |
| A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis BNT331, Placebo - Bacterial Vaginosis | Phase 1 | Completed | BioNTech SE | 102 | 2024-07-01 | 2026-10-05 |
| Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens Microbiological identification kits (ANAEROtest, STAPHYtest, ENTEROtest, NEFERMtest), Antibiotic therapy after the results of antibiotic sensitivity test (Mostly Oxacillin, Benzylpenicillin, Ceftriaxone, Doxycycline, Clindamycin), Suppositoria for vaginal microflora recovery (Giynoflor) - Bacterial Vaginosis | Phase 1 | Active not recruiting | Danylo Halytsky Lviv National Medical University | 200 | 2023-09-01 | 2024-09-27 |
| Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women Experimental: Low dose LABTHERA-001 capsule, Experimental: Medium dose LABTHERA-001 capsule, Experimental: High dose LABTHERA-001 capsule - Bacterial Vaginosis, Vaginal Disease | Phase 1 | Unknown | AtoGen Co. Ltd | 24 | 2022-11-02 | 2023-03-09 |
| First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories, Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories - Colpomycosis, Bacterial Vaginosis | Phase 1 | Unknown | Protelight Pharmaceuticals Australia PTY LTD | 50 | 2022-08-01 | 2023-12-11 |
| Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV) Cervicovaginal secretions, Metronidazole gel, Screening tests - Bacterial Vaginosis | Phase 1 | Withdrawn | Johns Hopkins University | 2022-03-01 | 2021-11-03 | |
| Pharmacokinetic Study of DARE-BV1 DARE-BV1 - Bacterial Vaginosis | Phase 1 | Completed | Daré Bioscience, Inc. | 21 | 2020-11-03 | 2022-04-29 |
| Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology Metronidazole - Bacterial Vaginosis, HIV Infections | Phase 1 | Completed | University of Toronto | 50 | 2015-08-01 | 2016-02-10 |
| GoldenCareTM for the Treatment of Bacterial Vaginosis GoldenCare, Metronidazole - Bacterial Vaginosis | Phase 1 / Phase 2 | Terminated | CDA Research Group, Inc. | 8 | 2013-02-01 | 2015-02-03 |
| Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14, Placebo - Bacterial Vaginosis | Phase 1 | Completed | The University of Texas Medical Branch, Galveston | 49 | 2013-01-01 | 2020-11-20 |
| Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes Vaginal capsules of lactobacilli - Bacterial Vaginosis | Phase 1 | Unknown | The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | 5000 | 2011-01-01 | 2011-08-23 |
| Safety Study of Lactobacillus Administered Vaginally to Healthy Women Low dose LACTIN-V applicator, Medium dose LACTIN-V applicator, High dose LACTIN-V applicator - Bacterial Vaginosis | Phase 1 | Completed | Osel, Inc. | 12 | 2007-11-01 | 2020-09-16 |
| Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery Lactobacilli GR-1 and RC-14 - Premature Birth, Bacterial Vaginosis | Phase 1 | Withdrawn | Mount Sinai Hospital, Canada | 2005-02-01 | 2017-08-31 | |
| Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis Metronidazole - Bacterial Vaginosis | Phase 1 / Phase 2 | Completed | Teva Pharmaceuticals USA | 579 | 2002-01-01 | 2024-08-19 |
Vaginosis, Bacterial (17) · Vaginal Diseases (3) · Vaginitis (3) · Bacterial Infections (2) · Candidiasis, Vulvovaginal (1) · Female Urogenital Diseases (1) · Genital Diseases, Female (1) · HIV Infections (1) · Premature Birth (1)
Bacterial Infections and Mycoses (17) · Female Urogenital Diseases and Pregnancy Complications (17) · Genital Diseases (17) · Infections (17) · Urogenital Diseases (17) · Female Urogenital Diseases (16) · Genital Diseases, Female (16) · Bacterial Infections (15) · Vaginal Diseases (14) · Vaginitis (14) · Blood-Borne Infections (1) · Candidiasis (1) · Communicable Diseases (1) · Immune System Diseases (1) · Immunologic Deficiency Syndromes (1)
Metronidazole (4) · Control Groups (2) · Amphotericin B (1) · Benchmarking (1) · Ceftriaxone (1) · Clindamycin (1) · Doxycycline (1) · Early Detection of Cancer (1) · Nystatin (1) · Penicillin G (1)
Changchun GeneScience Pharmaceutical Co., Ltd. (2) · AtoGen Co. Ltd (1) · BioNTech SE (1) · CDA Research Group, Inc. (1) · Danylo Halytsky Lviv National Medical University (1) · Daré Bioscience, Inc. (1) · Johns Hopkins University (1) · Massachusetts General Hospital (1) · Mount Sinai Hospital, Canada (1) · NEXBIOME THERAPEUTICS (1) · Osel, Inc. (1) · Protelight Pharmaceuticals Australia PTY LTD (1) · Teva Pharmaceuticals USA (1) · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine (1) · The University of Texas Medical Branch, Galveston (1)
United States (5) · Australia (3) · China (3) · Canada (1) · Kenya (1) · South Africa (1) · Ukraine (1)
Alan Bocking, MD, FRCSC (1) · Ashwin Chatwani, MD (1) · Christine Mauck, MD (1) · Christopher Argent, Dr. (1) · Christopher Moller, Dr. (1) · Craig Cohen, MD, MPH (1) · John McNeil, Professor (1) · Laura Ensign, PhD (1) · Rupert Kaul, MD/PhD (1) · Sunil K Jain, MD (1) · Yanfang Lee, Master (1) · Yulian Konechnyi (1)