Actively Recruiting
Contraceptive Efficacy Study of Ovaprene
Led by Daré Bioscience, Inc. · Updated on 2026-05-11
656
Participants Needed
27
Research Sites
193 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
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
Official 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 per subject history and investigator judgement
- Age 18 through 40 years, inclusive; approximately 66 subjects over 35 years old at visit 2
- In a relationship with a male partner aged at least 18 years, not known to be subfertile or infertile
- Have regular menstrual cycles of 21 to 35 days without heavy bleeding lasting longer than 5 days
- Willing to stop current contraception (except condoms) before Visit 2 and to have at least one menstrual bleed before using Ovaprene
- Injectable contraception users must be at least 9 months post last dose and have had at least 2 regular menstrual cycles
- 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 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 prior to visits and comply with subset procedures
You will not qualify if you...
- Currently pregnant or have a positive urine pregnancy test at screening
- Allergy to Ovaprene ingredients
- History of toxic shock syndrome
- History of hereditary hemochromatosis
- Breastfeeding an infant
- History of infertility including ectopic pregnancy, sterilization, endometriosis, or PID without subsequent pregnancy
- Use of medications causing subfertility such as gonadotropin-releasing hormone agonists
- Current postcoital bleeding
- Medical contraindications to pregnancy or medications contraindicated in pregnancy
- History of significant uterine prolapse, cystocele, or rectocele requiring surgery or pessary
- Positive HIV test at screening
- Abnormal HPV screening/cytology requiring treatment or follow-up
- Recent vaginal or cervical biopsy within 1 month or vaginal surgery within 3 months prior to screening
- Current drug or alcohol abuse impacting compliance
- Previous participation in Enrolled-Eligible Population
- Employee or immediate family of Sponsor, Investigators, or study staff
- Use of investigational drugs or devices within 30 days prior to screening
- Severe acute or chronic medical or psychiatric conditions or laboratory abnormalities increasing risk or interfering with results
- For microbiota/innate immunity subset: recent or anticipated systemic antibiotic or antiviral use except specific treatments
- Male partner with known or suspected HIV or other sexually transmitted infection
- Male partner allergic to Ovaprene ingredients
- Male partner previous participant in this study or recent investigational drug/device use
- Male partner with severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jessica Hatheway
CONTACT
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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