A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples

Study Overview
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Brief Summary
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This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.

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

Official Title
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A 3-way Cross-over, Multi-centre Clinical Investigation to Evaluate the Performance Rate of Natural Rubber Latex Condoms of Varying Thickness in Healthy Monogamous Couples

Conditions
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Control of Pregnancy, Prevention of Sexually Transmitted Infections

Intervention / Treatment
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* Device: NRL Condom


Participation Criteria
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Eligibility Criteria
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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 use one other 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 e.g. medication/medical devices used to treat erectile dysfunction. Exclusion Criteria: Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or control condoms or any lubrication products provided. 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. Either partner that requires to use/is using medication or preparations that are applied topically to the genitalia area or intravaginally other than that supplied for the investigation. 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 participant 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 investigators 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Condom: Thin NRL Condom<br>Following randomisation each couple will be given one set of 7 condoms as per randomisation schedule. Couples will return to the clinic site for collection of their next set of condoms on two additional occasions. Each couple will test a maximum of 21 condoms during their participation in the investigation. | Device: NRL Condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.<br>|
| Active Comparator: Reference condom A: Medium Thickness NRL Condom<br> | Device: NRL Condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.<br>|
| Active Comparator: Reference condom B: Thick NRL Condom<br> | Device: NRL Condom<br>* A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 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 A group | Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants. Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure. | within 2 hours following each coital act for each condom use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared clinical failure rate of condom use between the test condom group and the reference condom B group | Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants. Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure. | within 2 hours following each coital act for each condom use | 
| Compared clinical failure rate of condom use between the test condom group, the reference condom A group and reference condom B group | Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants. Clinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure. | 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 |  | 16 weeks | 
| Subject's experience on the use of each type of condoms [Acceptability and Tolerability] | Acceptability and tolerability as assessed by subject perceived questionnaires | 16 weeks |