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NCT05354050
Pharmacokinetic Study of DARE-BV1
Phase 1 trial testing DARE-BV1 in Bacterial Vaginosis in 21 participants. Completed in 2 December 2020.
18 November 2020
Quick facts
| Lead sponsor | Daré Bioscience, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 3 November 2020 |
| Primary completion | 18 November 2020 |
| Estimated completion | 2 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- DARE-BV1 — full drug profile →
Conditions studied
- Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
Sponsor
Daré Bioscience, Inc. — full company profile →
Who can join
18 and older, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Phase 1 pharmacokinetic study of a single-dose bioadhesive clindamycin 2% gel for bacterial vaginosis.
Mauck CK, Atiee GJ, McCulloh J, Reynolds L, et al · · 2022 · cited 1× · PMID 36418189 · DOI 10.1093/jac/dkac386
Verify or expand the search:
- PubMed search for NCT05354050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bacterial Vaginosis
Currently open trials in the same condition.
- NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
- NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
- NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
- NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
- NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting
Other Daré Bioscience, Inc. trials
Trials by the same sponsor.
- NCT05752526 — A Study of Diclofenac Gel in Women With Primary Dysmenorrhea · Phase 1 · completed
- NCT05765487 — Using Thermography to Assess the Affects of Sildenafil Cream, 3.6% · Phase 1 · completed
- NCT05367973 — Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women · Phase 1, PHASE2 · completed
- NCT05378269 — Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA · Phase 1, PHASE2 · completed
- NCT05418426 — A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMeno · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05354050 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daré Bioscience, Inc.
- Last refreshed: 29 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05354050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing