A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men

Not Applicable

Withdrawn

• Conditions: Ejaculation Delayed

• Registration Number: NCT05255770
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

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.

Study Timeline

• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-25
• Study Start: 2022-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-16
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To determine the effectiveness of the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation.	4 weeks for each assessment period (intervention duration)	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.

Secondary Outcome Measures

Name	Time	Method
To determine the effectiveness of the Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation.	4 weeks for each assessment period (intervention duration)	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.
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.	4 weeks for each assessment period (intervention duration)	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.
To evaluate the sexual pleasure when using the Test Condom A or Test Condom B compared with the Control NRL Condom.	4 weeks for each assessment period (intervention duration)	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.
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.	4 weeks for each assessment period (intervention duration)	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.
Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]	19 weeks	Acceptability and in-use tolerability as assessed by subject perceived questionnaires.