WithdrawnNot Applicable

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

Stopped: Change of the product development strategy

0Started 2022-04

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexMALE

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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.

What they're measuring

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)

Trial details

NCT IDNCT05255770

SponsorReckitt Benckiser Healthcare (UK) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01

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