Could a monthly ring replace the pill? new study tests Hormone-Free contraceptive

NCT ID NCT06127199

Disease control Sponsor: Daré Bioscience, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing Ovaprene, a non-hormonal vaginal ring worn for a month at a time to prevent pregnancy. About 656 women aged 18–40 will use the ring for up to 13 menstrual cycles. Researchers will track how many become pregnant and how safe and acceptable the ring is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Ovaprene non-hormonal intravaginal ring
What this could lead to: If successful, Ovaprene could offer a hormone-free, user-controlled contraceptive option that is placed monthly.
What could go wrong: This is a single-arm, open-label study without a comparison group, so effectiveness may be overestimated. The ring may not prevent pregnancy as well as hormonal methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 656 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 exclusionary results on human papilloma virus (HPV) screening/cytology (subjects\>/=21 years old) at screening or require treatment or follow-up for an abnormal Pap smear or HPV test that would be needed during the study. * 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 * Have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results * Microbiota/innate immunity subset only: --systemic use in the last 2 weeks prior to screening or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), candidiasis, or bacterial vaginosis(BV) diagnosed at Visit 1) or antivirals; * If male partner has or is suspected to have had an HIV infection or other sexually transmitted infection * if male partner has a known sensitivity or allergy to the ingredients in Ovaprene * If male partner has previously participated in this study or has taken any investigational drug or used any investigational device within 30 days prior to the female subject's screening * If the male partner has a history of any severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or could interfere with the interpretation of trial results.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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Locations

Amicis Research Center
ACTIVE_NOT_RECRUITING

Newhall, California, 91321, United States
Boston Medical Center
COMPLETED

Boston, Massachusetts, 02118, United States
Carolina Women's Research and Wellness Center
COMPLETED

Durham, North Carolina, 27713, United States
Case Western
COMPLETED

Cleveland, Ohio, 44106, United States
Columbia University
COMPLETED

New York, New York, 10032, United States
Del Sol Research Management, LLC
RECRUITING

Tucson, Arizona, 85715, United States
Eastern Virginia Medical School
COMPLETED

Norfolk, Virginia, 23507, United States
Einstein College of Medicine
COMPLETED

The Bronx, New York, 10461, United States
Emory University
COMPLETED

Atlanta, Georgia, 30322, United States
Essential Access Health
COMPLETED

Los Angeles, California, 90010, United States
Essential Health Access (Berkeley)
COMPLETED

Berkeley, California, 94710, United States
Magee-Women's Hospital
COMPLETED

Pittsburgh, Pennsylvania, 15213, United States
MomDoc Women's Health Research
ACTIVE_NOT_RECRUITING

Scottsdale, Arizona, 85251, United States
Oregon Health and Science University
COMPLETED

Portland, Oregon, 97239, United States
Praetorian Pharmaceutical Research, LLC
ACTIVE_NOT_RECRUITING

Marrero, Louisiana, 70072, United States
Precision Trials AZ
RECRUITING

Phoenix, Arizona, 85032, United States
Rutgers Medical Center
COMPLETED

Newark, New Jersey, 07103, United States
Seattle Clinical Research Center
RECRUITING

Seattle, Washington, 98104, United States

Contact Email: •••••@•••••
The Johns Hopkins University
COMPLETED

Baltimore, Maryland, 21224, United States
University of California at Davis
COMPLETED

Sacramento, California, 95817, United States
University of California, San Francisco
WITHDRAWN

San Francisco, California, 94143, United States
University of Cincinnati
COMPLETED

Cincinnati, Ohio, 45267, United States
University of Colorado Denver
COMPLETED

Aurora, Colorado, 80045, United States
University of Hawaii
COMPLETED

Honolulu, Hawaii, 96826, United States
University of Pennsylvania Penn Obstetric Gynecology Associates
COMPLETED

Philadelphia, Pennsylvania, 19104, United States
University of Utah
COMPLETED

Salt Lake City, Utah, 84132, United States
Washington University
COMPLETED

St Louis, Missouri, 63110, United States

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