Actively Recruiting
A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene
Led by Daré Bioscience, Inc. · Updated on 2026-05-11
656
Participants Needed
27
Research Sites
21 weeks
Total Duration
On this page
Sponsors
D
Daré Bioscience, Inc.
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Ovaprene, a non-hormonal intravaginal ring, to study its contraceptive effectiveness, safety, and acceptability in people assigned female at birth who are sexually active and desire contraception. This open-label, single-arm study is conducted across multiple centers to observe how well Ovaprene works in preventing pregnancy over a 12-month period. Participants will use Ovaprene as their sole method of contraception throughout the study. Before starting Ovaprene, participants must stop their current contraceptive methods (except condoms) and experience at least one menstrual cycle. The study includes a detailed screening and follow-up process to monitor participants' health and contraceptive use. During the study, participants will attend scheduled clinic visits for assessments including pregnancy testing and health evaluations. Researchers will measure the pregnancy rate over 12 months to determine contraceptive effectiveness. Additional monitoring includes safety assessments and adherence to using Ovaprene only. The total study duration for each participant is about one year, with ongoing follow-up visits to ensure safety and collect data.
CONDITIONS
Brief Title
Contraceptive Efficacy Study of Ovaprene
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception
- General good health as determined by subject history and investigator judgment
- Aged 18 through 40 years, inclusive; approximately 66 subjects over 35 years old at visit 2 will be enrolled
- In a relationship with a person assigned male at birth who is at least 18 years old and not known to be subfertile or infertile
- Have regular menstrual cycles (21 to 35 days) without heavy bleeding lasting longer than 5 days when not on hormonal contraception
- Willing to stop current contraception (except condoms) before Visit 2 and experience at least one menstrual bleed before using Ovaprene
- Participants using injectable contraception must be at least 9 months post last dose and have had at least 2 regular menstrual cycles
- After stopping current contraception, willing to abstain from vaginal sex or use condoms before first Ovaprene insertion
- Not actively desiring pregnancy for at least 13 months and willing to accept unknown pregnancy risk
- Expect to have at least 4 acts of heterosexual vaginal intercourse per cycle during the study
- Willing to use Ovaprene as the sole contraception method during the study
- Agree not to participate in other clinical trials during the study
- Willing and able to comply with study procedures and attend scheduled visits
- For microbiota/innate immunity and colposcopy subsets: willing to avoid vaginal sex and intravaginal products for 48 hours before clinic visits and comply with subset procedures
You will not qualify if you...
- Currently pregnant or have a positive pregnancy test at screening
- Allergy to any ingredients in Ovaprene
- History of toxic shock syndrome
- History of hereditary hemochromatosis
- Currently breastfeeding an infant
- History suggestive of infertility such as ectopic pregnancy, sterilization, endometriosis, pelvic inflammatory disease without subsequent pregnancy, or use of medications causing subfertility
- Current postcoital bleeding
- Medical contraindications to pregnancy or chronic use of medications contraindicated in pregnancy
- History of significant uterine prolapse, cystocele, or rectocele requiring surgery or pessary
- Positive HIV test at screening
- Abnormal HPV screening or Pap smear requiring treatment or follow-up during study
- Vaginal or cervical biopsy within 1 month or vaginal surgery within 3 months before screening
- Known drug or alcohol abuse affecting study compliance
- Previous inclusion in the Enrolled-Eligible Population
- Direct employee or immediate family of sponsor, investigators, or study staff
- Use of investigational drugs or devices within 30 days before screening
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities increasing risk or interfering with results
- For microbiota/innate immunity subset: systemic antibiotics or antivirals use in last 2 weeks except for certain infections
- Male partner has or is suspected of having HIV or other sexually transmitted infections
- Male partner allergic to Ovaprene ingredients
- Male partner previously participated in this study or used investigational drugs/devices within 30 days
- Male partner has severe medical or psychiatric conditions increasing risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants use the Ovaprene non-hormonal intravaginal ring as their sole method of contraception.
Monthly visits for up to 12 months
Trial Site Locations
Total: 27 locations
1
Precision Trials AZ
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
MomDoc Women's Health Research
Scottsdale, Arizona, United States, 85251
Active, Not Recruiting
3
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
Actively Recruiting
4
Essential Health Access (Berkeley)
Berkeley, California, United States, 94710
Completed
5
Essential Access Health
Los Angeles, California, United States, 90010
Completed
6
Amicis Research Center
Newhall, California, United States, 91321
Active, Not Recruiting
7
University of California at Davis
Sacramento, California, United States, 95817
Completed
8
University of California, San Francisco
San Francisco, California, United States, 94143
Withdrawn
9
University of Colorado Denver
Aurora, Colorado, United States, 80045
Completed
10
Emory University
Atlanta, Georgia, United States, 30322
Completed
11
University of Hawaii
Honolulu, Hawaii, United States, 96826
Completed
12
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States, 70072
Active, Not Recruiting
13
The Johns Hopkins University
Baltimore, Maryland, United States, 21224
Completed
14
Boston Medical Center
Boston, Massachusetts, United States, 02118
Completed
15
Washington University
St Louis, Missouri, United States, 63110
Completed
16
Rutgers Medical Center
Newark, New Jersey, United States, 07103
Completed
17
Columbia University
New York, New York, United States, 10032
Completed
18
Einstein College of Medicine
The Bronx, New York, United States, 10461
Completed
19
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States, 27713
Completed
20
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Completed
21
Case Western
Cleveland, Ohio, United States, 44106
Completed
22
Oregon Health and Science University
Portland, Oregon, United States, 97239
Completed
23
University of Pennsylvania Penn Obstetric Gynecology Associates
Philadelphia, Pennsylvania, United States, 19104
Completed
24
Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Completed
25
University of Utah
Salt Lake City, Utah, United States, 84132
Completed
26
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Completed
27
Seattle Clinical Research Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
C
Christine Mauck, MD
J
Jessica Hatheway
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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