Trial Outcomes & Findings for Evaluation of Polyurethane Male Condoms (NCT NCT04622306)

Last Updated: 2023-10-06

Results Overview

To confirm each experimental condom is non-inferior to the control condom with respect to total clinical failure rate. The definition of total clinical failure rate as specified in ISO 29943-1:2017 will be used. The Total Clinical Failure Rate is Defined as the Number of Condoms with at least One Acute Failure Event (e.g. Clinical Breakage or Clinical Slippage) Divided by the Number of Condoms Used During Intercourse; Typically Reported as a Percentage; Any Condom which Experiences Multiple Clinical Failure Events Only Count as a Single Clinical Failure. To be eligible for inclusion in the non-inferiority analysis the each couple had to have used at least one of the appropriate experimental condoms and at least one control condom. This means that the numbers of participants and condoms reported in each of the two non-inferiority comparisons will differ.

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.

Results posted on

2023-10-06

Participant Flow

The total recruitment target was 300 couples consented couples (600 participants). Each couple to participate in each of the 6 arms using 5 condoms of each type in a randomized block sequence. The six randomized sequences were ABC, ACB, BAC, BCA, CAB, CBA. Each couple received 5 of the first assigned condom at the start of the study along with a set of 5 blank condom reports. Couples also received a penis measuring kit. The couples were expected to use all 15 condoms within 9 weeks.

Participant milestones

Participant milestones
Measure	Couples Assigned to Sequence ABC Couples assigned at random to use the condoms in order Condom A first followed by Condom B then Condom C.	Couples Assigned to Sequence ACB Couples assigned at random to use the condoms in order Condom A first followed by Condom C then Condom B.	Couples Assigned to Sequence BAC Couples assigned at random to use the condoms in order Condom B first followed by Condom A then Condom C.	Couples Assigned to Sequence BCA Couples assigned at random to use the condoms in order Condom B first followed by Condom C then Condom A.	Couples Assigned to Sequence CAB Couples assigned at random to use the condoms in order Condom C first followed by Condom A then Condom B.	Couples Assigned to Sequence CBA Couples assigned at random to use the condoms in order Condom C first followed by Condom B then Condom A.
Couples Used First Assigned Condom Set STARTED	48	50	48	51	53	50
Couples Used First Assigned Condom Set COMPLETED	46	48	48	51	51	45
Couples Used First Assigned Condom Set NOT COMPLETED	2	2	0	0	2	5
Couples Used Second Assigned Condom Set STARTED	46	48	48	51	51	45
Couples Used Second Assigned Condom Set COMPLETED	46	48	48	51	51	45
Couples Used Second Assigned Condom Set NOT COMPLETED	0	0	0	0	0	0
Couples Used Third Assigned Condom Set STARTED	46	48	48	51	51	45
Couples Used Third Assigned Condom Set COMPLETED	46	48	46	48	51	45
Couples Used Third Assigned Condom Set NOT COMPLETED	0	0	2	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Couples Assigned to Sequence ABC Couples assigned at random to use the condoms in order Condom A first followed by Condom B then Condom C.	Couples Assigned to Sequence ACB Couples assigned at random to use the condoms in order Condom A first followed by Condom C then Condom B.	Couples Assigned to Sequence BAC Couples assigned at random to use the condoms in order Condom B first followed by Condom A then Condom C.	Couples Assigned to Sequence BCA Couples assigned at random to use the condoms in order Condom B first followed by Condom C then Condom A.	Couples Assigned to Sequence CAB Couples assigned at random to use the condoms in order Condom C first followed by Condom A then Condom B.	Couples Assigned to Sequence CBA Couples assigned at random to use the condoms in order Condom C first followed by Condom B then Condom A.
Couples Used First Assigned Condom Set Withdrawal by Subject	2	2	0	0	2	5
Couples Used Third Assigned Condom Set Withdrawal by Subject	0	0	2	3	0	0

Baseline Characteristics

The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=600 Participants The total number of couples consented was 300 (600 participants). These were randomly assigned to the 6 arms of the study.
Age, Categorical Male · <=18 years	0 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Age, Categorical Male · Between 18 and 65 years	300 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Age, Categorical Male · >=65 years	0 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Age, Categorical Female · <=18 years	0 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Age, Categorical Female · Between 18 and 65 years	300 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Age, Categorical Female · >=65 years	0 Participants n=300 Participants • The participants were recruited as monogamous sexually active couples. The total recruited populated consisted therefore of 300 men and 300 women.
Sex: Female, Male Female	300 Participants n=600 Participants
Sex: Female, Male Male	300 Participants n=600 Participants
Ethnicity (NIH/OMB) Number recruited · Hispanic or Latino	144 Participants n=600 Participants
Ethnicity (NIH/OMB) Number recruited · Not Hispanic or Latino	456 Participants n=600 Participants
Ethnicity (NIH/OMB) Number recruited · Unknown or Not Reported	0 Participants n=600 Participants
Region of Enrollment United States	600 participants n=600 Participants
Number of participants completing study as per protocol	568 Participants n=600 Participants

PRIMARY outcome

Timeframe: Self Completion of Questionnaires Within 12 Hours of condom use. Questionnaires returned to investigators when receiving next set of 5 condoms. All sets of questionnaires returned within 9 weeks of couple starting.

Population: The number of participants and condoms used for the non-inferiority assessment of Condom A versus Condom C and the equivalent numbers in the non-inferiority assessment of Condom B versus Condom C differ because some men found Condom B to be too small to use.

Outcome measures

Outcome measures
Measure	Polyurethane Condoms A Used in Non-inferiority Analysis Condom A of Versus Condom C n=1193 Condom uses The number of participants using Condom A included in the non-inferiority analysis of Polyurethane Condom A versus Control Latex Condom C.	Latex Condoms C Used in Non-inferiority Analysis of Condom A Versus Condom C n=1212 Condom uses The number of participants using Control Latex Condom C included in the non-inferiority analysis of Polyurethane Condom A versus Control Latex Condom C.	Polyurethane Condoms B Used in Non-inferiority Analysis of Condom B Versus Condom C n=1142 Condom uses The number of participants using Condom B included in the non-inferiority analysis of Polyurethane Condom A versus Control Latex Condom C.	Latex Condom C Used in Non-inferiority Analysis of Condom B Versus Condom C n=1193 Condom uses The number of participants using Control Condom C included in the non-inferiority analysis of Polyurethane Condom B versus Control Latex Condom C.
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Primary Analysis of Study Data · Clinical Breaks	15 Condom uses	10 Condom uses	22 Condom uses	9 Condom uses
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Primary Analysis of Study Data · Clinical slippages	13 Condom uses	6 Condom uses	13 Condom uses	6 Condom uses
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Primary Analysis of Study Data · Successful Uses	1165 Condom uses	1196 Condom uses	1107 Condom uses	1178 Condom uses
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. · Clinical Breaks	0 Condom uses	0 Condom uses	12 Condom uses	5 Condom uses
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. · Clinical slippages	0 Condom uses	0 Condom uses	8 Condom uses	6 Condom uses
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017. Post hoc Analysis of Condom B versus Condom C where male penis length limited to ≤ 170 mm. · Successful Uses	0 Condom uses	0 Condom uses	866 Condom uses	904 Condom uses

Adverse Events

Polyurethane Condom A

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Polyurethane Condom B

Serious events: 10 serious events

Other events: 85 other events

Deaths: 0 deaths

Control Latex Condom C

Serious events: 20 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Polyurethane Condom A n=337 participants at risk Polyurethane Condom A (002) Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates	Polyurethane Condom B n=392 participants at risk Polyurethane Condom B (001) Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates	Control Latex Condom C n=332 participants at risk Commercial Natural Rubber Latex Male Condom Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates
Skin and subcutaneous tissue disorders Discomfort caused by irritation, burning sensation, itching or rash	1.2% 4/337 • Number of events 4 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.	2.6% 10/392 • Number of events 10 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.	6.0% 20/332 • Number of events 20 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.

Other adverse events

Other adverse events
Measure	Polyurethane Condom A n=337 participants at risk Polyurethane Condom A (002) Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates	Polyurethane Condom B n=392 participants at risk Polyurethane Condom B (001) Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates	Control Latex Condom C n=332 participants at risk Commercial Natural Rubber Latex Male Condom Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B: Condom functionality study to determine failure rates
Skin and subcutaneous tissue disorders Mild to moderate discomfort	12.2% 41/337 • Number of events 41 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.	21.7% 85/392 • Number of events 85 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.	26.2% 87/332 • Number of events 87 • Participants completed report forms after each condom use. Each condom report elicited information about specific adverse event usually experienced when using condoms including discomfort caused by burning, irritation and itching sensations, rashes, constriction, decreased sensitivity and dryness. Participants were expected to use all 15 condoms within 9 weeks, which can therefore be regarded as the monitoring period for adverse event. All adverse events were rated by severity (mild, moderate, severe), duration (only while wearing condom, 1 to 10 minutes after condom removed, 11 to 59 minutes after condom removed and more than 59 minutes after condom removed.

Additional Information

Mr Grant R Burt

Sagami

Phone: +33 607 54 52 41

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place