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
Daré Bioscience, Inc.
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.
Eligibility
- Age range
- 22–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of written informed consent prior to any study-specific procedures. 2. Premenopausal women aged 22-50 years inclusive at the time of screening visit. 3. Positive result for genital hrHPV (types 16, 18, or 'other') on at least 2 tests over the span of at least 12 months (history of persistent hrHPV infection for at least 12 months), based on review of participant's medical records. The visit 1 screening genital hrHPV test may be the second positive test. 4. Generally, in good health with no clinically significant disease as determined by the Investigator. 5. Re…
Interventions
- DrugLopinavir / ritonavir
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
Location
- Applied Research Center of Arkansas/Cornerstone Clinic for WomenLittle Rock, Arkansas