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Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

A Multicenter, Open-Label, Randomized, Two-Period, Crossover Non-inferiority Trial to Assess the Functionality of Male Condoms With a Silicone Elastomer Vaginal Ring

NCT01755741•International Partnership for Microbicides, Inc.

View on ClinicalTrials.gov

Summary

This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
•2. Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
•3. Healthy on the basis of medical history;
•4. Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
•5. Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
•6. Agree to use only the condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
•7. Agree to not use other vaginal products, except menstrual absorption products (e.g. tampons) and study lubricant during the trial;
•8. Available for all visits and consent to follow all procedures scheduled for the trial;
•9. At low risk for HIV infection.

Exclusion Criteria

•1. Males with untreated erectile dysfunction;
•2. Female with positive pregnancy test;
•3. Either partner allergic to natural latex or vaginal lubricants such as Astroglide ®;
•4. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
•5. Currently using condoms for protection against sexually transmitted infection;
•6. Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
•7. Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
•8. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.);
•9. Current participation in a study or other research involving a drug, device or other product;
•10. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.

Locations (2)

California Family Health Council

Berkeley, California, United States

California Family Health Council

Los Angeles, California, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 29, 2018

Enrollment

ACTUAL participants

Conditions

Human Immunodeficiency Virus

Interventions

Placebo Vaginal Ring

COMBINATION_PRODUCT

Condom

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

Inclusion Criteria

Exclusion Criteria

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