Contraceptive Efficacy Study of Ovaprene

NCT06127199 | Recruiting DMC FDA Device

• 1 other identifier: DR-OVP-002
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 27

Brief Summary

This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene.

Conditions

Contraception

Keywords

Device; Non-hormonal

Outcome Measures

Primary Outcomes (1)

• Determination of pregnancy rate

  Measurement of number of pregnancies over 13 menstrual cycles (13-cycle Pearl Index)

  12 months

Study Arms (1)

Ovaprene

EXPERIMENTAL

Device: Ovaprene

Interventions

Ovaprene DEVICE

Non-hormonal intravaginal ring

Ovaprene

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception.
• General good health, by subject history and per investigator judgement
• Age 18 through 40 years, inclusive; approximately 66 subjects \>35 years old at visit 2 will be the Enrolled-Eligible Population
• In a relationship with a person assigned male at birth who meets eligibility criteria below.
• At least 18 years old, not known to be subfertile or infertile
• Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heave bleeding that lasts longer than 5 days
• Be willing to stop their current method of contraception (with the exception of condoms) before Visit 2. Participants must experience at least one subsequent menstrual bleed before inserting Ovaprene. Participants using injectable contraception must be at least 9 months post their last dose at screening and have experienced at least 2 subsequent regular menstrual bleeds that were part of cycles of 21-35 days. After stopping their current method of contraception, subjects must either abstain fro vaginal sex or use condoms before inserting their first Ovaprene
• Not be actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy
• Expect to engage in at least 4 acts of heterosexual vaginal intercourse per cycle during the study.
• Be willing to only use Ovaprene as the sole method of contraception over the course of the study
• Agree not to participate in any other clinical trials during the course of the study
• Be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits
• Microbiota/innate immunity and colposcopy subsets only:
• Be willing to avoid vaginal sex and using tampons and other intravaginal products for 48 hours prior to clinic visits; and be willing to comply with subset procedures

You may not qualify if:

• Currently pregnant and/or have a positive urine pregnancy test at screening.
• Have an allergy to the ingredients in Ovaprene
• Have a history of toxic shock syndrome
• Have a history of hereditary hemochromatosis
• Be breastfeeding an infant
• Have a history suggestive of infertility, defined as any of the following: known history of ectopic pregnancy or other fertility problem; sterilization/permanent contraception; endometriosis or hospitalization for pelvic inflammatory disease (PID) unless subject has had a subsequent spontaneous intrauterine pregnancy; or use of medications that could cause subfertility such as gonadotropin-releasing hormone agonists
• Currently have postcoital bleeding
• Have contraindications to pregnancy (medical condition) or chronic use of medications contraindicated in pregnancy
• Have a history of clinically significant uterine prolapse, cystocele, or rectocele that has required surgical intervention or pessary use
• Positive human immunodeficiency virus (HIV) test at screening
• Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3 months prior to screening
• Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance
• Have previously been included in the Enrolled-Eligible Population
• Is a direct employee or immediate family member of the Sponsor company, site Investigators or study staff
• Have taken any investigational drug or used any investigational device within the 30 days prior to screening

Sponsors & Collaborators

• Daré Bioscience, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (27)

Precision Trials AZ

Phoenix, Arizona, 85032, United States

RECRUITING

MomDoc Women's Health Research

Scottsdale, Arizona, 85251, United States

RECRUITING

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

RECRUITING

Essential Health Access (Berkeley)

Berkeley, California, 94710, United States

COMPLETED

Essential Access Health

Los Angeles, California, 90010, United States

ACTIVE NOT RECRUITING

Amicis Research Center

Newhall, California, 91321, United States

RECRUITING

University of California at Davis

Sacramento, California, 95817, United States

COMPLETED

University of California, San Francisco

San Francisco, California, 94143, United States

WITHDRAWN

University of Colorado Denver

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

University of Hawaii

Honolulu, Hawaii, 96826, United States

ACTIVE NOT RECRUITING

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States

ACTIVE NOT RECRUITING

The Johns Hopkins University

Baltimore, Maryland, 21224, United States

COMPLETED

Boston Medical Center

Boston, Massachusetts, 02118, United States

ACTIVE NOT RECRUITING

Washington University

St Louis, Missouri, 63110, United States

COMPLETED

Rutgers Medical Center

Newark, New Jersey, 07103, United States

COMPLETED

Columbia University

New York, New York, 10032, United States

COMPLETED

Einstein College of Medicine

The Bronx, New York, 10461, United States

COMPLETED

Carolina Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

ACTIVE NOT RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

COMPLETED

Case Western

Cleveland, Ohio, 44106, United States

COMPLETED

Oregon Health and Science University

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

University of Pennsylvania Penn Obstetric Gynecology Associates

Philadelphia, Pennsylvania, 19104, United States

COMPLETED

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

COMPLETED

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

COMPLETED

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

RECRUITING

Study Officials

• Christine Mauck, MD

  Daré Bioscience, Inc.

  STUDY DIRECTOR

Central Study Contacts

Christine Mauck, MD

CONTACT

www.ovaprenestudy.com; cmauck@darebioscience.com

Jessica Hatheway

CONTACT

www.ovaprenestudy.com; jhatheway@darebioscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (27)