Safety and Acceptability Study of a Non-Hormonal Ring

Completed · Not applicable

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT03598088

Run by

Daré Bioscience, Inc.

People needed

38

Starts

2018-05-23

Expected to finish

2019-11-15

Last updated by the study team

2022-06-08

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

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)
• Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
• History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
• Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
• Nugent score greater than or equal to 7
• Systemic use in the last two weeks or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), vaginal candidiasis, or bacterial vaginosis (BV) diagnosed at Visit 1, or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g., acyclovir or valacyclovir). Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in treatment of headaches or dysmenorrhea.
• Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for Grading of the Severity of Adverse Events or clinically significant lab abnormalities as determined by the investigator (see Section 13.5 for link to DAIDS table)
• Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
• Inadequate sperm in endocervical aspirate during baseline testing without any device, despite adequate mucus and presence of sperm in vaginal pool

Where it is running

• University of California at Davis — Sacramento, California, United States
• Segal Trials — North Miami, Florida, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania Penn Obstetric Gynecology Associates — Philadelphia, Pennsylvania, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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