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NCT05354050 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study of DARE-BV1

A Phase 1 study, sponsored by Daré Bioscience.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT05354050: Completed Phase 1 study, sponsored by Daré Bioscience.

NCT05354050 is a Phase 1 study that has completed, run by Daré Bioscience. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05354050, a Phase 1 study, has completed, sponsored by Daré Bioscience.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

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).

Primary Outcome

Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations

Interventions

  • DRUG DARE-BV1

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2020-11-03
Est. Completion 2020-12-02
Phase Phase 1
Daré Bioscience

5 total trials

What the finished NCT05354050 record still lists

NCT05354050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which DARE-BV1 is the first listed.

NCT05354050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05354050 about?

NCT05354050 is a clinical study titled "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).

What is the current status of trial NCT05354050?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2020-11-03. Estimated completion is 2020-12-02.

What interventions are being tested in trial NCT05354050?

The interventions under investigation include: DARE-BV1 (DRUG).

Who is sponsoring clinical trial NCT05354050?

This trial is sponsored by Daré Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05354050's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05354050, the US trial registry maintained by the National Library of Medicine. NCT05354050 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.