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Pharmacokinetic Study of DARE-BV1

NCT05354050 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-04-29

No results posted yet for this 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).

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

DARE-BV1

2% Clindamycin 100 MG

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Christine Mauck, MD · Dare Bioscience, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2020-11-18
Completion
2020-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05354050 on ClinicalTrials.gov