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DARE-HPV for Persistent High-Risk Human Papillomavirus (hrHPV)

This study is testing if a vaginal capsule called DARE-HPV (a combination of lopinavir and ritonavir) can help clear persistent high-risk human papillomavirus (hrHPV) infection. You may be able to join if you are a premenopausal woman between 22 and 50 years old and have had hrHPV (types 16, 18, or 'other') for at least 12 months. The main goal is to see if the hrHPV infection clears up within 30, 60, or 90 days after treatment. The study will compare different doses and treatment lengths of DARE-HPV to a placebo (an inactive substance). This study is currently unclear on its recruitment status and aims to enroll 118 participants.

Study design
This interventional study plans to enroll 118 women. It will compare different doses and treatment durations of DARE-HPV against a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for treatment effectiveness will be measured at 90 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07601074

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

Recruiting
PHASE2Ages 22–50InterventionalTreatment
Daré Bioscience, Inc.
~118 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Lopinavir / ritonavir

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy Endpoint
Measured over 90 days

Conditions

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

Explore related trials

Human Papillomavirus InfectionHPV

Where it's being run

4 sites across 4 states
Arizona1
Arkansas1
Utah1
Washington1

Study leadership

  • Andrea Thurman, MD · STUDY_DIRECTOR · Daré Bioscience, Inc.

Who to contact

Jessica Hatheway, MBA
[email protected]
(858)736-6026
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Heterosexual abstinence
Vasectomized male partner (provided that the male partner is the sole sexual partner of the female participant with childbearing potential and that the vasectomized partner has received medical assessment of the surgical success);
Oral or transdermal combined ethinyl estradiol/progestin hormonal contraception associated with inhibition of ovulation;
Oral, injectable or implantable progestogen-only hormone contraception associated with inhibition of ovulation (e.g., Depo-Provera™, Nexplanon, Slynd);
Any effective copper intrauterine device/levonorgestrel intrauterine system;
Female sterilization by tubal occlusion or bilateral salpingectomy;
Supracervical hysterectomy. 9. Ability and willingness to attend the necessary visits to the study center. 10. Ability to comprehend all study related documentation, including written informed consent form, and complete all study-related tasks including daily diary. 11. Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.

What this trial measures

  • Efficacy Endpoint90 days

    Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment