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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Daré Bioscience, Inc.
Study ID
NCT07601074
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • High-risk Human Papillomavirus Infection
  • Human Papilloma Virus (HPV)

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jul 17, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DARE-HPV-LD 14 day
    14 day administration of DARE-HPV low dose
  • Active Comparator: DARE-HPV-LD 21 day
    21 day administration of DARE-HPV low dose
  • Active Comparator: DARE-HPV-HD 14 day
    14 day administration of DARE-HPV high dose
  • Active Comparator: DARE-HPV-HD 21 day
    21 day administration of DARE-HPV high dose
  • No Intervention: Placebo 14 day
    14 day administration of placebo product
  • No Intervention: Placebo 21 day
    21 day administration of placebo product

Primary Outcome Measure

Efficacy Endpoint [ Time Frame: 90 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Precision Clinical Trials-ArizonaPhoenixArizona85032
Ali Hamieh
[email protected]
602-931-4507
Valerie Sorkin-Wells, MD (PRINCIPAL_INVESTIGATOR)
Applied Research Center of Arkansas/Cornerstone Clinic for WomenLittle RockArkansas72205
Allie Barker
[email protected]
501-954-7822
Alpine Research Organization, Inc.LaytonUtah84041
Chelsie Harding
[email protected]
801-559-0410
Justin Mansfield, MD (PRINCIPAL_INVESTIGATOR)
Seattle Clinical Research CenterSeattleWashington98104
Recruitment Department
[email protected]
206 522 3330
Rebecca Dunsmoor-Su, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Precision Clinical Trials-Arizona· Phoenix, AZApplied Research Center of Arkansas/Cornerstone Clinic for Women· Little Rock, ARAlpine Research Organization, Inc.· Layton, UTSeattle Clinical Research Center· Seattle, WA

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