A Clinical Investigation to Assess the Effectiveness of Benzocaine in NRL Condoms in Healthy Adul… (NCT05840172) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Investigation to Assess the Effectiveness of Benzocaine in NRL Condoms in Healthy Adult Men Who Feel They Ejaculate Too Quickly During Vaginal Sex
Germany300 participantsStarted 2023-10-19
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects and their female partners have provided written informed consent.
✓. Subjects and their female partners between the ages of \>= 18 years and =\< 60 years.
✓. Subjects and their female partners must have no health condition in their medical history.
✓. Subject must be sexually active having regular intercourse.
✓. Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
✓. Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.
✓. Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale.
Exclusion criteria
✕. Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation.
✕. Subject or his female partner with a current history of alcohol or drug abuse.
✕. Subjects and their female partners with a history of or are suffering from anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
✕. Subjects and their female partners with a history of, suspected to have, or be at increased risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
What they're measuring
1
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
Timeframe: 4 weeks for each assessment period (intervention duration)
✕. Subject and/or his female partner have a physical or psychological condition that would prevent them from following investigation procedures - including but not limited to the following:
✕. urological disease,
✕. ongoing significant psychiatric disorder not controlled by medication
✕. history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra