Synthetic Male Condom Slippage-Breakage Study

Study Overview
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Brief Summary
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This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.

Detailed Description
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Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.

Official Title
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Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)

Conditions
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Contraceptive, Sexually Transmitted Diseases

Intervention / Treatment
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* Device: Test Product
* Device: Control Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give written or electronic informed consent Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews Agree to have vaginal intercourse at least once weekly Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy) Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM) Agree not to wear any genital piercing jewellery while using the study condoms Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms Agree to return any unopened condoms Reachable by telephone Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology Male partner agrees to ejaculate during vaginal intercourse Exclusion Criteria: Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health Female partner self-reported as pregnant Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products Unable to follow instructions or strictly adhere to the visit schedule At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia) Currently using condoms for protection against a known sexually transmitted infection Taking any externally applied medication or oral medication to treat a genital condition Male partner has had difficulty achieving or maintaining an erection or achieving ejaculation in the last month prior to screening under typical circumstances/ conditions. Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Synthetic Male Condom | Device: Test Product<br>* Synthetic Male Condom<br>* Other names: Synthetic Male Condom;|
| Active Comparator: Control Product<br>Latex Male Condom | Device: Control Product<br>* Latex Male Condom<br>* Other names: Latex Male Condom;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Clinical Failure Rate | The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse. | Throughout the study. Each participating couple will engage in 8 acts over a 4 week period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Breakage Rate | The number of condoms that broke during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse. | Throughout the study. Each participating couple will engage in 8 acts over a 4 week period. | 
| Clinical Complete Slippage Rate | The number of condoms that slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse. | Throughout the study. Each participating couple will engage in 8 acts over a 4 week period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synthetic Male Condom, Slippage-Breakage Study, ISO 29943-1