ContraceptionNCT06127199
Contraceptive Efficacy Study of Ovaprene
A study testing Ovaprene in people with Contraception, run by Daré Bioscience, Inc. at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Ovaprene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 27 sitesUnited States
- Study dates
- 19 Dec 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 4 recruiting
- Completed
Emory University
Atlanta, Georgia, 30322
- Completed
University of Colorado Denver
Aurora, Colorado, 80045
- Completed
The Johns Hopkins University
Baltimore, Maryland, 21224
- Completed
Essential Health Access (Berkeley)
Berkeley, California, 94710
- Completed
Boston Medical Center
Boston, Massachusetts, 02118
- Completed
University of Cincinnati
Cincinnati, Ohio, 45267
- Completed
Case Western
Cleveland, Ohio, 44106
- Completed
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
- Completed
University of Hawaii
Honolulu, Hawaii, 96826
- Completed
Essential Access Health
Los Angeles, California, 90010
- Completed
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
- Completed
Columbia University
New York, New York, 10032
- Completed
Rutgers Medical Center
Newark, New Jersey, 07103
- Recruiting
Amicis Research Center
Newhall, California, 91321
Tyrone Business Developer, 818-924-4708, tyrone.rosales@amicisresearch.com
Jerry Izu, MD
- Completed
Eastern Virginia Medical School
Norfolk, Virginia, 23507
- Completed
University of Pennsylvania Penn Obstetric Gynecology Associates
Philadelphia, Pennsylvania, 19104
- Recruiting
Precision Trials AZ
Phoenix, Arizona, 85032
Director of Operations, 602-931-4507, ali@precisiontrials.com
Valerie Sorkin-Wells, MD
- Completed
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213
- Completed
Oregon Health and Science University
Portland, Oregon, 97239
- Completed
University of California at Davis
Sacramento, California, 95817
- Completed
University of Utah
Salt Lake City, Utah, 84132
- Withdrawn
University of California, San Francisco
San Francisco, California, 94143
- Completed
MomDoc Women's Health Research
Scottsdale, Arizona, 85251
- Recruiting
Seattle Clinical Research Center
Seattle, Washington, 98104
Meranda Ruiz, 206 522 3330 ext. 2, recruitment@seattlecrc.com
Ashley Fuller, MD
- Completed
Washington University
St Louis, Missouri, 63110
- Completed
Einstein College of Medicine
The Bronx, New York, 10461
- Recruiting
Del Sol Research Management, LLC
Tucson, Arizona, 85715
Recruitment Manager, 520-257-3881, kgoodin@delsolresearch.com
C. Paige Brainard, MD
About this study
Official title: A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene
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
- Being tested
- Ovaprene
- Keywords
- Device, Non-hormonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvapreneDevice
Non-hormonal intravaginal ring
| Study group | Role | What they receive |
|---|---|---|
| Ovaprene | Experimental | Not described Receives: Device: Ovaprene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of pregnancy rate
Measurement of number of pregnancies over 13 menstrual cycles (13-cycle Pearl Index)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Dec 2023
- Primary completion30 Apr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Christine Mauck, MD, Study director, Daré Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127199
- Sponsor's protocol ID
- DR-OVP-002
- Status last verified
- May 2026
- First submitted
- 7 Nov 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Final decision on what will be shared has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene
- ClinicalTrials.gov ID
- NCT06127199
- Acronym / sponsor ID
- DR-OVP-002
- Conditions
- Contraception
- Keywords
- Device, Non-hormonal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Daré Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovaprene | Experimental | Device: Ovaprene |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OvapreneNon-hormonal intravaginal ring | Device | Ovaprene |
Primary outcome
Determination of pregnancy rate
Time frame: 12 months
Measurement of number of pregnancies over 13 menstrual cycles (13-cycle Pearl Index)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided. Final decision on what will be shared has not yet been determined.
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Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Mauck, MD study director
Daré Bioscience, Inc.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovaprene in people with Contraception, run by Daré Bioscience, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Mauck, MD (www.ovaprenestudy.com, cmauck@darebioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of pregnancy rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.