15 completed, 4 unknown, 2 not yet recruiting, 2 terminated. 23 Phase 2, 6 Phase 3, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 23 | Completed 15, Unknown 4, Not yet recruiting 2, Terminated 2 |
| Phase 3 | 6 | Completed 3, Unknown 2, Not yet recruiting 1 |
| Phase 1 | 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 |
|---|---|---|---|---|---|---|
| Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients BPR-101 capsules:Investigational product for the treatment of BV, Placebo：matching the investigational product in appearance, dosage form, and route of administration - Bacterial Vaginosis | Phase 2 | Not yet recruiting | Chengdu Syncor Pharmaceutical Co., Ltd. | 80 | 2026-04-15 | 2026-03-19 |
| Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis Lactobacillus gasseri KABP®064 10e9 CFU/capsule, Placebo (maltodextrin) - Vaginosis, Bacterial, Bacterial Vaginosis | Phase 2 / Phase 3 | Not yet recruiting | Kaneka Americas Holding Inc. | 160 | 2026-04-01 | 2026-04-14 |
| 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 |
| Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs Menstrual Cup - Bacterial Vaginosis, Vaginal Microbiome | Phase 2 | Completed | Rush University Medical Center | 408 | 2023-02-13 | 2026-08-24 |
| Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb) Vaginal Lactobacillus Dual Probiotic Capsules, Placebo - Bacterial Vaginosis | Phase 2 | Completed | Guangdong Longchuangji Pharmaceutical Co., Ltd. | 66 | 2023-01-03 | 2026-02-18 |
| Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition LACTIN-V, Placebo - Bacterial Vaginosis, HIV Infections | Phase 2 | Completed | University of California, San Francisco | 45 | 2021-05-10 | 2024-08-13 |
| Suppression Of Bacterial Vaginosis (BV) [SUBVert] Placebo, TOL-463 - Bacterial Vaginosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 81 | 2019-09-09 | 2023-02-22 |
| TOL-463 Phase 2 Study for Vaginitis TOL-463 - Bacterial Vaginosis, Vulvovaginal Candidiasis | Phase 2 | Completed | Toltec Pharmaceuticals, LLC | 106 | 2016-07-15 | 2018-03-09 |
| LACTIN-V Study for Recurrent Bacterial Vaginosis Lactobacillus crispatus CTV-05, Metronidazole, Placebo - Bacterial Vaginosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 228 | 2016-06-03 | 2020-03-04 |
| Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis 5% Monolaurin Vaginal Gel, Placebo - Bacterial Vaginosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 109 | 2016-04-14 | 2018-12-28 |
| Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis HUDC_VT(Glucose 200mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg) - Bacterial Vaginosis, HUDC_VT | Phase 2 | Unknown | Haudongchun Co., Ltd. | 150 | 2016-03-22 | 2017-12-02 |
| Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG, PLACEBO VAGINAL TABLET - BACTERIAL VAGINOSIS | Phase 2 | Terminated | Alfasigma S.p.A. | 392 | 2015-04-01 | 2016-10-10 |
| A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis SYM-1219, Placebo - Bacterial Vaginosis | Phase 2 | Completed | Symbiomix Therapeutics | 215 | 2014-05-01 | 2020-11-13 |
| BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study Placebo, Boric acid, Metronidazole - Bacterial Vaginosis | Phase 2 / Phase 3 | Completed | University of British Columbia | 13 | 2014-04-01 | 2016-10-27 |
| 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 |
| Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate), Placebo - Bacterial Vaginosis, Candidiasis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 234 | 2011-04-01 | 2014-10-06 |
| Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV) 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, 3.0% SPL7013 Gel - Bacterial Vaginosis | Phase 2 | Completed | Starpharma Pty Ltd | 132 | 2010-08-01 | 2019-06-06 |
| A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis Lactofiltrum + Metronidazole, Metronidazole - Bacterial Vaginosis | Phase 2 / Phase 3 | Unknown | Avva Rus, JSC | 90 | 2010-07-01 | 2010-07-21 |
| The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis Yogurt supplemented with L. rhamnosus fiti, Yogurt not supplemented with a probiotic strain. - Bacterial Vaginosis | Phase 2 / Phase 3 | Completed | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 150 | 2010-06-01 | 2010-12-13 |
| Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis Trimo-San gel - Bacterial Vaginosis | Phase 2 / Phase 3 | Completed | University of New Mexico | 184 | 2009-09-01 | 2020-04-22 |
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Vaginosis, Bacterial (23) · Candidiasis, Vulvovaginal (3) · Vaginitis (3) · Candidiasis (2) · HIV Infections (2) · Vaginal Diseases (2) · Acquired Immunodeficiency Syndrome (1) · Communicable Diseases (1) · Diarrhea (1) · Gonorrhea (1) · Recurrence (1) · Sexually Transmitted Diseases (1) · Trichomonas Infections (1) · Trichomonas Vaginitis (1)
Bacterial Infections (23) · Bacterial Infections and Mycoses (23) · Female Urogenital Diseases (23) · Female Urogenital Diseases and Pregnancy Complications (23) · Genital Diseases (23) · Genital Diseases, Female (23) · Infections (23) · Urogenital Diseases (23) · Vaginal Diseases (21) · Vaginitis (20) · Disease Attributes (3) · Mycoses (3) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Vulvar Diseases (3)
Metronidazole (6) · Benchmarking (2) · TOL-463 (2) · Dosage Forms (1) · Drug Administration Routes (1) · Glucose (1) · Menstrual Hygiene Products (1) · Miconazole (1) · Sodium Chloride (1) · boric acid (1) · maltodextrin (1) · secnidazole (1)
National Institute of Allergy and Infectious Diseases (NIAID) (4) · Alfasigma S.p.A. (1) · Avva Rus, JSC (1) · CDA Research Group, Inc. (1) · Chengdu Syncor Pharmaceutical Co., Ltd. (1) · Guangdong Longchuangji Pharmaceutical Co., Ltd. (1) · Haudongchun Co., Ltd. (1) · Kaneka Americas Holding Inc. (1) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (1) · NEXBIOME THERAPEUTICS (1) · National Institute for Medical Research, Tanzania (1) · Osel, Inc. (1) · Rush University Medical Center (1) · Starpharma Pty Ltd (1) · Symbiomix Therapeutics (1)
United States (13) · China (2) · Kenya (2) · Tanzania (2) · Canada (1) · Russia (1) · South Africa (1) · South Korea (1)
Anke Hemmerling, MD, MPH, PhD (1) · Anne Macek, MD (1) · Ashwin Chatwani, MD (1) · Craig R Cohen, MD MPH (1) · Craig R Cohen, MD, MPH (1) · FengXia Xue, Doctor of Medicine(M.D.) (1) · John Changalucha, MSc (1) · Kate V Meriwether, MD (1) · Konia Trouton, MD (1) · Lyudmila Kobeleva, MD, PhD (1) · Melinda Zeron Mullins, MD, Ph.D (1) · Nicodemus Butamanya, MD (1) · Raffaella Tacchi, MD (1) · Sergey Dvoryanskiy, MD, DrSc (1) · WonSeog Choi (1)
PMID 20644497, PMID 20801446, PMID 21992977, PMID 25935783, PMID 26210791, PMID 28697102, PMID 29474292, PMID 30184181, PMID 30807423, PMID 32402161, PMID 33207004, PMID 35113809, PMID 39516733, PMID 40194532, PMID 40206350, PMID 42326018, PMID 42678149
R01AI170564 (1), R01HD098978 (1)