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This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Condom: Thin NRL Condom | Experimental | 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. |
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| Reference condom A: Medium Thickness NRL Condom | Active Comparator |
| |
| Reference condom B: Thick NRL Condom | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRL Condom | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Bangkok | Thailand |
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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.
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Each condom will be contained within an individual foil packet on which all branding will been masked. All the condom types will be masked in the same manner and identical boxes will be used for the test and comparator condoms A and B.
| 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 |