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

Reckitt Benckiser

Status

Withdrawn

Conditions

Ejaculation Delayed

Treatments

Device: Test condom B (NRL condom with 3% benzocaine paste)

Device: Control NRL condom

Device: Test condom A (NRL condom with 5% benzocaine paste)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05255770

5061901

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 (a minimum frequency of once a week).
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.

Exclusion criteria

Subject or his female partner with alcohol or drug abuse.
Subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
Subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
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.
Subjects on medication that is contraindicated, which may affect erection.
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.
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.
Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

0 participants in 3 patient groups

Test condom A (NRL condom with 5% benzocaine paste)

Experimental group

Description:

Following randomisation each subject will be given one set of 8 condoms as per randomisation schedule. After reporting at least 4 duration records (from vaginal entry to ejaculation), subjects will return to the clinical site for collection of their next set of condoms.

Treatment:

Device: Test condom B (NRL condom with 3% benzocaine paste)

Device: Control NRL condom

Device: Test condom A (NRL condom with 5% benzocaine paste)

Test condom B (NRL condom with 3% benzocaine paste)

Experimental group

Description:

Treatment:

Device: Test condom B (NRL condom with 3% benzocaine paste)

Device: Control NRL condom

Device: Test condom A (NRL condom with 5% benzocaine paste)

Control NRL condom