Safety and Acceptability Study of a Non-Hormonal Ring

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

Detailed Description
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The purpose of this clinical trial is to assess the ability of Ovaprene™ to prevent sperm from penetrating midcycle cervical mucus. In addition, safety, release of ingredients, acceptability and fit will be assessed.

Official Title
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Safety and Acceptability Study of a Non-Hormonal Ring

Conditions
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Contraception

Intervention / Treatment
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* Device: Ovaprene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Sexually Active Women<br>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<br>* non-hormonal contraceptive ring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |