Recruiting
Phase 2

DARE-HPV

Sponsor:

Daré Bioscience, Inc.

Code:

NCT07601074

Conditions

Human Papilloma Virus (HPV)

High-risk Human Papillomavirus Infection

Eligibility Criteria

Sex: Female

Age: 22 - 50

Healthy Volunteers: Not accepted

Interventions

Lopinavir / ritonavir

Study Details

Brief 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.

Conditions

Human Papilloma Virus (HPV)

High-risk Human Papillomavirus Infection

Study ID

NCT07601074

Start date

Jul 17, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 50

Healthy Volunteers: Not accepted

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. Regular menstrual cycle with an approximate 28-day cycle OR women who are amenorrheic due to effective contraception (such as levonorgestrel intrauterine system, or continuous oral contraception).
6. Agree to refrain from vaginal douching, insertion of intravaginal devices (e.g., tampons, menstrual cups), and use of condoms for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.
7. Agree to abstain from all vaginal and oral intercourse for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.
8. Women at risk of pregnancy must use a highly effective form of birth control (confirmed by the Investigator) for the entire duration of the study. Rhythm methods and consistent use of condoms will not be considered as highly effective methods of birth control. Highly effective forms of birth control include:

  • 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.

Exclusion Criteria:

1. Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study.
2. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the participant at risk because of her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
3. Cytological abnormality of the uterine cervix defined as LSIL or mild cervical intraepithelial neoplasia (CIN1), or HSIL or moderate (CIN 2) or severe (CIN 3) histology, as proven by cytology or colposcopic biopsy collected within the 12 months prior to screening or cytology at screening.
4. Pregnant, breastfeeding, or lactating women (WOCBP must have a negative urine pregnancy test at screening and at the start of treatment \[i.e., Day 1\]).
5. Active pelvic infection (positive for gonorrhea or chlamydial infection, positive test and symptoms for bacterial vaginosis, candida vaginitis or trichomonal vaginitis). Participants with positive results can be treated and re-tested once during screening.
6. Positive result for hepatitis B, hepatitis C antibody or human immunodeficiency virus.
7. Currently taking systemic immunosuppressants, biologics, intra-vaginal preparations, or any prescription that in the opinion of the Investigator could be a potential safety issue or interfere with the interpretation of the results.
8. Previous exposure to lopinavir/ritonavir (within 3 months prior to screening), contraindication to the use of lopinavir/ritonavir or known allergy, hypersensitivity, or intolerance to any component of lopinavir/ritonavir excipients.
9. Recent history (within 3 months prior to screening) of Stevens-Johnson syndrome, erythema multiforme, urticaria, or angioedema.
10. Receipt of any investigational product within 30 days or 5 half-lives prior to dosing.
11. Participants who, in the opinion of the Investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular, the study restrictions and risks involved).

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Lopinavir / ritonavir

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

Primary outcome measure

  • Efficacy Endpoint [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Precision Clinical Trials-Arizona

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Principal Investigator:

Valerie Sorkin-Wells, MD

Applied Research Center of Arkansas/Cornerstone Clinic for Women

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Alpine Research Organization, Inc.

Recruiting

Layton, Utah, United States, 84041

Contacts

Principal Investigator:

Justin Mansfield, MD

Seattle Clinical Research Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Rebecca Dunsmoor-Su, MD

More Information

Sponsor

Daré Bioscience, Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • HPV
  • hrHPV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Daré Bioscience, Inc. on 2026-08-25.