Evaluating the contraceptive effectiveness of Ovaprene

A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene

This study is testing how well the Ovaprene, a new non-hormonal vaginal ring, works as a birth control option for people assigned female at birth who are looking for contraception.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 656 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Daré Bioscience, Inc. (industry)
• Locations: 27 sites (Phoenix, Arizona and 26 other locations)
• Trial ID: NCT06127199 on ClinicalTrials.gov

What this trial studies

This study investigates the contraceptive effectiveness, safety, and acceptability of Ovaprene, a non-hormonal intravaginal ring. It is a multi-center, single-arm, open-label study involving sexually active individuals assigned female at birth who are at risk for pregnancy and seeking contraception. Participants will stop their current contraceptive methods before inserting Ovaprene and will be monitored for its effectiveness over time. The study aims to gather data on the device's performance in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates include sexually active individuals assigned female at birth, aged 18 to 40, who desire contraception and are in good health.

Not a fit: Patients who are not sexually active, those with known fertility issues, or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new non-hormonal contraceptive option for individuals seeking effective birth control.

How similar studies have performed: Other studies have explored non-hormonal contraceptive methods, but the specific approach of Ovaprene is relatively novel.

Eligibility criteria

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.

Where this trial is running

Phoenix, Arizona and 26 other locations

• Precision Trials AZ — Phoenix, Arizona, United States (RECRUITING)
• MomDoc Women's Health Research — Scottsdale, Arizona, United States (ACTIVE_NOT_RECRUITING)
• Del Sol Research Management, LLC — Tucson, Arizona, United States (RECRUITING)
• Essential Health Access (Berkeley) — Berkeley, California, United States (COMPLETED)
• Essential Access Health — Los Angeles, California, United States (COMPLETED)
• Amicis Research Center — Newhall, California, United States (ACTIVE_NOT_RECRUITING)
• University of California at Davis — Sacramento, California, United States (COMPLETED)
• University of California, San Francisco — San Francisco, California, United States (WITHDRAWN)
• University of Colorado Denver — Aurora, Colorado, United States (COMPLETED)
• Emory University — Atlanta, Georgia, United States (COMPLETED)
• University of Hawaii — Honolulu, Hawaii, United States (COMPLETED)
• Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, United States (ACTIVE_NOT_RECRUITING)
• The Johns Hopkins University — Baltimore, Maryland, United States (COMPLETED)
• Boston Medical Center — Boston, Massachusetts, United States (COMPLETED)
• Washington University — St Louis, Missouri, United States (COMPLETED)
• Rutgers Medical Center — Newark, New Jersey, United States (COMPLETED)
• Columbia University — New York, New York, United States (COMPLETED)
• Einstein College of Medicine — The Bronx, New York, United States (COMPLETED)
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States (COMPLETED)
• University of Cincinnati — Cincinnati, Ohio, United States (COMPLETED)
• Case Western — Cleveland, Ohio, United States (COMPLETED)
• Oregon Health and Science University — Portland, Oregon, United States (COMPLETED)
• University of Pennsylvania Penn Obstetric Gynecology Associates — Philadelphia, Pennsylvania, United States (COMPLETED)
• Magee-Women's Hospital — Pittsburgh, Pennsylvania, United States (COMPLETED)
• University of Utah — Salt Lake City, Utah, United States (COMPLETED)
• Eastern Virginia Medical School — Norfolk, Virginia, United States (COMPLETED)
• Seattle Clinical Research Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Christine Mauck, MD

Conditions: Contraception, Device, Non-hormonal