The investigation is to evaluate the effectiveness of benzocaine in two NRL condoms compared with a standard NRL control without benzocaine in prolonging time to ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.
In this investigation, two NRL condoms with benzocaine paste (Test condom A and Test condom B) will be evaluated against a standard NRL male condom (Control condom) in prolonging time to ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
300
In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types.
In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types.
SGS proderm GmbH
Hamburg, Germany
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. The Intravaginal Ejaculation Latency Time (IELT) is the duration from the start of vaginal entry (vaginal penetration into the female partner) until the start of intravaginal ejaculation (release of semen). It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom B compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
To Determine the Effectiveness of Benzocaine of the Test Condom A and Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation for an Increase of 2, 3 and 4 Minutes
Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the proportion of participants who achieved an increase of 2, 3 and 4 minutes from baseline in each of the Test Condom A and Test Condom B compared to the Control NRL Condom. The odds ratio compares the odds of achieving a given duration increase (e.g., ≥2 minutes) with Test Condom A or B to the odds of achieving the same increase with the Control Condom. An odds ratio greater than 1 suggests the test condom is more effective than the control in helping participants reach that milestone. This outcome measure data was collected and analyzed for 150 male participants.
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In each assessment period, subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period. Subjects will repeat the assessment period each to test all 3 condom types.
Time frame: 4 weeks for each assessment period (intervention duration)
To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom
The outcome was assessed by the measure of EMSEX (Event-level Male Sexual) pleasure scale questionnaire, a subject perceived questionnaire, at the end of a 4-week assessment period when using Test Condom A or Test Condom B compared with the Control NRL Condom. EMSEX pleasure scale is a 11-item scale which assesses sexual pleasure at the event level. For each item, the range spans the entirety of the potential range from 0 (zero) to 100 (one hundred). This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
To Evaluate the Subject's Improvement at "Lasting Longer" for Both the Test Condom A and Test Condom B Compared With the Control NRL Condom
The outcome was assessed by the measure of Patient Global Impression of Change (PGIC), a subject perceived questionnaire, at the end of a 4-week assessment period when using Test Condom A or Test Condom B compared with the Control NRL Condom. The PGIC is a 7-point response scale (Very much better, Better, Little better, No change, Little worse, Worse, Very much worse). This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
Participant - Subject Perceived Questionnaire (SPQ)
Upon completion of each condom assessment period, each participant was required to complete a SPQ. The questionnaire collected the following information (including but not limited to): experience with condom use, acceptability, preference and tolerability. This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
Total Clinical Failure Rate of Each Type of Condoms
Number of clinical failure events per usages (clinical slippage or clinical breakage) reported by participants. The number of outcomes are based on the number of sexual encounters while wearing one of the three condoms being tested. This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 4 weeks for each assessment period (intervention duration)
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
Overall proportion of participants with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per participant. The result is presented by the counts of all AEs sorted by SOC and PT for male participants. This outcome measure data was collected and analyzed for 150 male participants.
Time frame: 19 weeks
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
Overall proportion of participants with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per participant. The result is presented by the counts of all AEs sorted by SOC and PT for male participants. This outcome measure data was collected and analyzed for 150 female participants.
Time frame: 19 weeks