Clinical trial NCT05255770: A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men
Official title: A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ejaculation Delayed
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The condom types will be tested in a 3-way cross-over design where subjects will be randomised to use each of the 3 condom types in a defined order, according to the randomisation schedule.
Primary purpose: OTHER

Brief summary: This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.

Detailed description: In this clinical 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects and their female partners between the ages of \>=18 years and =\<60 years.
2. Subjects and their female partners must have no health condition in their medical history.
3. Subject must be sexually active having regular intercourse (a minimum frequency of once a week).
4. Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
5. Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.

Exclusion Criteria:

1. Subject or his female partner with alcohol or drug abuse.
2. Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
3. Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
4. Subject and/or his female partner with urological disease or genitourinary surgery; 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; relevant genital surgery; a female partner with vaginal complaints; any broken skin or wounds in the genital area.
5. Subjects on medication that is contraindicated, which may affect erection.
6. Subject and/or his female partner have any medication which may affect the safety of the subject, including but not limited to benzocaine drug interactions such as Sulphonamides and cholinesterase inhibitors.
7. Subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder, hepatitis B or C, human immunodeficiency virus (HIV) infection or having had penile implant surgery.
8. Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.

Primary outcomes:
measure: To determine the effectiveness 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)
Secondary outcomes:
measure: To determine the effectiveness of the Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation.
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: To determine the effectiveness 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.
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: To evaluate the sexual pleasure when using the Test Condom A or Test Condom B compared with the Control NRL Condom.
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: 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.
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]
timeFrame: 19 weeks
Other outcomes:
Locations:
Study officials:
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