This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
470
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.
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.
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
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.
Time frame: within 2 hours following each coital act for each condom use
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.
Time frame: 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.
Time frame: within 2 hours following each coital act for each condom use
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
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: 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)
Time frame: 12 weeks