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NOT YET RECRUITING
NCT07601074
PHASE2

A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)

Sponsor: Daré Bioscience, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days. The study will look at two different doses of DARE-HPV and two different treatment durations of 14 and 21 days compared to a placebo group or 14 or 21 days of treatment.

Official title: A Phase 2a, Multi-Center, Placebo-Controlled, Double-Blinded, Randomized, Dose Ranging Study of the Preliminary Efficacy of DARE-HPV to Treat Persistent High-Risk Human Papillomavirus (HPV) Genital Infection

Key Details

Gender

FEMALE

Age Range

22 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2026-06

Completion Date

2027-12

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Lopinavir / ritonavir

A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.

Locations (1)

Applied Research Center of Arkansas/Cornerstone Clinic for Women

Little Rock, Arkansas, United States