A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples

Study Overview
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Brief Summary
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This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.

Detailed Description
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In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.

Official Title
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A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom

Conditions
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Control of Pregnancy, Prevention of Sexually Transmitted Infections

Intervention / Treatment
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* Device: Polyurethane (PU) condom
* Device: Natural Rubber Latex (NRL) condom


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: A male and a female subject aged: 18 - 60 years inclusive. All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months. All couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks). The female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal. Couples must agree not to use drugs or non-investigational devices that can affect sexual performance. Main Exclusion Criteria: Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms. Either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination. Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes. Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear. Male partners that have known erectile or ejaculatory dysfunction. A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation. Any subject who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/ AIDS or has a previous history of high-risk behaviour as judged by the investigator. Female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use. A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyurethane (PU) condom<br>Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. | Device: Polyurethane (PU) condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.<br>Device: Natural Rubber Latex (NRL) condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.<br>|
| Experimental: Natural Rubber Latex (NRL) condom<br>Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. After use of at least 5 condoms, couples will return to the clinic site for collection of their next set of condoms. Each couple will test a maximum of 14 condoms during their participation in the investigation. | Device: Polyurethane (PU) condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.<br>Device: Natural Rubber Latex (NRL) condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared clinical failure rate of condom use between the test condom group and the reference condom group | Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects. | within 2 hours following each coital act for each condom use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance (clinical slippage rate) of the Polyurethane (PU) condom | Clinical slippage rate is calculated as the number of condoms with at least 1 clinical slippage event divided by the number of condoms used during intercourse, reported as a percentage. Clinical slippage events, defined in ISO 29943-1:2017, will be reported by subjects. A clinical slippage is defined as a condom slipping off completely during intercourse or during withdrawal from the vagina. Slippage that occur because the user failed to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex are to be record as non-clinical slippage, these events are considered user failures. | within 2 hours following each coital act for each condom use | 
| Performance (clinical slippage rate) of the Natural Rubber Latex (NRL) condom | Clinical slippage rate is calculated as the number of condoms with at least 1 clinical slippage event divided by the number of condoms used during intercourse, reported as a percentage. Clinical slippage events, defined in ISO 29943-1:2017, will be reported by subjects. A clinical slippage is defined as a condom slipping off completely during intercourse or during withdrawal from the vagina. Slippage that occur because the user failed to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex are to be record as non-clinical slippage, these events are considered user failures. | within 2 hours following each coital act for each condom use | 
| Performance (clinical breakage rate) of the Polyurethane (PU) condom | Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects. | within 2 hours following each coital act for each condom use | 
| Performance (clinical breakage rate) of the Natural Rubber Latex (NRL) condom | Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by subjects. | within 2 hours following each coital act for each condom use | 
| Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3 |  | 12 weeks | 
| Subject's experience on the use of each type of condoms [Acceptability and Tolerability | Acceptability and tolerability as assessed by subject perceived questionnaires (designed by following ISO 29943-1) | 12 weeks |