Evaluation of Polyurethane Male Condoms

Study Overview
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Brief Summary
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The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

Detailed Description
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The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male condom made of natural rubber latex. Couples entering the study will be expected to use 5 of each type of the 3 condoms in a randomised order. The identity of the condoms will be masked to both the couples and the investigators. The aim will be to recruit 300 heterosexual with the intent of achieving a minimum 1,000 uses of each condom type. Couples will report condom use events using a condom report form. The primary information collected will relate to condom breakage and slippage of the penis during use. The total clinical failure rates (breakage and slippage) of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

Official Title
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A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom

Conditions
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Contraception, Prevention of Sexually Transmitted Infections

Intervention / Treatment
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* Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 and 45 (inclusive) Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy) Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology Willing and able to give electronic informed consent Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires Have vaginal intercourse at least once weekly Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry In a mutually exclusive monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation Both study partners have previous experience using male condoms Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms Male partner agrees to ejaculate during vaginal intercourse Agree to (or partner) hold the condom at the base of the erect penis during withdrawal Agree to return any condoms that break during use Agree to return any unopened condoms Reachable by telephone Exclusion Criteria: Currently participating in another similar clinical study Female partner self-reported as pregnant Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products Unable to follow study requirements, use instructions or attend study visits or exchanges Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.) Currently using condoms for protection against a known STI Taking any internally applied medication to treat a genital condition that could interact with the study condom Male partner has used medication that has caused erectile dysfunction, or had difficulty achieving/maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions Male has had a prostatectomy Any self-reported genitourinary condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.

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 |
| --- | --- |
| Active Comparator: Control Latex Condom C<br>Commercial Natural Rubber Latex Male Condom | Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B<br>* Condom functionality study to determine failure rates<br>|
| Experimental: Polyurethane Condom A<br>Polyurethane Condom A (002) | Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B<br>* Condom functionality study to determine failure rates<br>|
| Experimental: Polyurethane Condom B<br>Polyurethane Condom B (001) | Device: Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B<br>* Condom functionality study to determine failure rates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. | To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure. To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ. | Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting. |