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
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period.
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
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the change from baseline with the Test Condom B compared to the Control NRL Condom, over a 4-week assessment period.
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
Subjects will be recording the duration (time in minutes:seconds) from vaginal entry to ejaculation for each condom use. The outcome is evaluated by the proportion of subjects who achieve 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.
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 is 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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IIn 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 subject's improvement at "lasting longer" for both the Test Condom A and Test Condom B compared with the Control NRL Condom
The outcome is 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).
Time frame: 4 weeks for each assessment period (intervention duration)
Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]
Acceptability and in-use tolerability as assessed by subject perceived questionnaires
Time frame: 4 weeks for each assessment period (intervention duration)
Total clinical failure rate of each type of condoms
Number of clinical failure events (clinical slippage or clinical breakage) reported by subjects.
Time frame: 4 weeks for each assessment period (intervention duration)
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject
Time frame: 19 weeks