RECRUITING

Contraceptive Efficacy Study of Ovaprene

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-19

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06127199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * 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	* 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: * 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.

Inclusion Criteria

Exclusion 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.
* 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

* 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:
* 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.

Contacts and Locations

Study Contact

Christine Mauck, MD

CONTACT

www.ovaprenestudy.com

cmauck@darebioscience.com

Jessica Hatheway

CONTACT

www.ovaprenestudy.com

jhatheway@darebioscience.com

Principal Investigator

Christine Mauck, MD

STUDY_DIRECTOR

Daré Bioscience, Inc.

Study Locations (Sites)

Essential Health Access (Berkeley)

Berkeley, California, 94710

United States

Essential Access Health

Los Angeles, California, 90010

United States

University of California at Davis

Sacramento, California, 95817

United States

University of California, San Francisco

San Francisco, California, 94143

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

Emory University

Atlanta, Georgia, 30322

United States

University of Hawaii

Honolulu, Hawaii, 96826

United States

The Johns Hopkins University

Baltimore, Maryland, 21224

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Washington University

Saint Louis, Missouri, 63110

United States

Rutgers Medical Center

Newark, New Jersey, 07103

United States

Einstein College of Medicine

Bronx, New York, 10461

United States

Columbia University

New York, New York, 10032

United States

University of Cincinnati

Cincinnati, Ohio, 45267

United States

Case Western

Cleveland, Ohio, 44106

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

University of Pennsylvania Penn Obstetric Gynecology Associates

Philadelphia, Pennsylvania, 19104

United States

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Eastern Virginia Medical School

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Daré Bioscience, Inc.

Christine Mauck, MD, STUDY_DIRECTOR, Daré Bioscience, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-12-19

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Device
Non-hormonal

Additional Relevant MeSH Terms

Contraception