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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
470
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.
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
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.
Time frame: within 2 hours following each coital act for each condom use
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.
Time frame: 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.
Time frame: 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
Time frame: 16 weeks
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Subject's experience on the use of each type of condoms [Acceptability and Tolerability]
Acceptability and tolerability as assessed by subject perceived questionnaires
Time frame: 16 weeks