Safety and Acceptability Study of a Non-Hormonal Ring

NCT03598088 | Completed Results FDA Device

• 2 other identifiers: DR-OVP-0011R44HD095724-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

Brief Summary

This is a feasibility, multi-center, open-label, non-significant risk device study for a non-hormonal contraceptive ring.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use.

  All participants had fewer than 5 progressively motile sperm per high power field (PMS/HPF) in all cycles during Ovaprene use.

  Baseline to OVP PCTa at 175 Days

Other Outcomes (13)

• Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device.

  Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs)

• Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device.

  OVP Cycle A Visit 13 (Day 121) to Visit 14 (Day 122) and OVP Cycle B Visit 18 (Day 156) to Visit 19 (Day 157).

• Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device.

  175 days

Study Arms (1)

Healthy Sexually Active Women

OTHER

Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene and the Caya diaphragm throughout the course of the trial. The purpose of the Caya Post Coital Test (PCT) cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated.

Device: Ovaprene

Interventions

Ovaprene DEVICE

non-hormonal contraceptive ring

Healthy Sexually Active Women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Females and their male partners to be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-50 years, inclusive
• General good health, by volunteer history and per investigator judgment
• History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
• History of Pap tests and follow-up consistent with standard medical practice or willing to undergo a Pap test at Visit 1.
• Protected from pregnancy by female tubal sterilization
• Willing to abstain from or engage in intercourse with and without condoms and to abstain from other vaginal activity as required in the protocol
• In a mutually monogamous relationship for at least the last four months with a male partner who:
• Is at least 18 years old;
• Has no known risk for Sexually Transmitted Infections (STIs);
• Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and
• Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
• Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and genital tract sample collection
• Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

You may not qualify if:

• History of hysterectomy
• Vasectomy in male partner
• Sterility or known history of sperm dysfunction in male partner
• Within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome.
• Current use of any hormonal contraceptive or a copper IUD (intra-uterine device), or use of Depo-Provera within the last 120 days
• Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
• Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
• Either device does not appropriately fit volunteer, as determined by clinician
• Inability of the volunteer to insert, position, and/or remove either device, even with assistance
• History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of Ovaprene™ or Caya, for either the volunteer or her male partner
• In the last four months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women or male partners with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
• Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV
• Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
• Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
• Known current drug or alcohol abuse which could impact study compliance. (This is defined as any illicit drug use or more than 15 alcoholic drinks per week)

Sponsors & Collaborators

• Daré Bioscience, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (6)

University of California at Davis

Sacramento, California, 95817, United States

Location

Segal Trials

North Miami, Florida, 33161, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Penn Obstetric Gynecology Associates

Philadelphia, Pennsylvania, 19104, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Results Point of Contact

• Title: Jessica Hatheway VP, Clinical Operations
• Organization: Dare Bioscience, Inc.

jhatheway@darebioscience.com

858-926-7655

Study Officials

• Nadene A. Zack, MS

  Sr Director, Clinical Operations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 26, 2018
• Study Start: May 23, 2018
• Primary Completion: October 17, 2019
• Study Completion: November 15, 2019
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-06

Locations

US (6)