Clinical Trials Logo

Clinical Trial Summary

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 of bacterial vaginosis. Patients will be evaluated at three time points: a Day 1 Screening/Randomization visit, a Day 7-14 Interim Assessment visit, and a Day 21 - 30 Test of Cure [TOC] visit). Patients who discontinue prematurely from the study will receive a safety follow-up phone call between Day 21-30. The total study duration will be approximately one month for each individual patient.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04370548
Study type Interventional
Source Daré Bioscience, Inc.
Contact
Status Completed
Phase Phase 3
Start date June 16, 2020
Completion date December 7, 2020

See also
  Status Clinical Trial Phase
Completed NCT03930745 - Suppression Of Bacterial Vaginosis (BV) [SUBVert] Phase 2
Completed NCT02863536 - A Study of the New Medical Device Polybactum® N/A
Completed NCT03187457 - PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" N/A
Recruiting NCT02185456 - Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis Phase 0
Completed NCT02150655 - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women Phase 0
Completed NCT01450462 - Vitamin D and Sexual Health N/A
Recruiting NCT01558388 - Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy Phase 4
Completed NCT01471457 - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis Phase 2/Phase 3
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00545181 - Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial N/A
Completed NCT00556179 - Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis Phase 4
Completed NCT02236156 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Phase 3
Not yet recruiting NCT05434104 - The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study N/A
Completed NCT01335373 - Observational Program Neo-Penotran® Forte N/A
Completed NCT00752193 - Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System. N/A
Active, not recruiting NCT00536848 - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients Phase 2/Phase 3
Completed NCT00510614 - Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study Phase 0
Suspended NCT00207480 - Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women Phase 1
Recruiting NCT05278130 - Serial Screening and Treatment of Bacterial Vaginosis Trial N/A
Completed NCT02905890 - The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Phase 4