Status:
WITHDRAWN
A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men
Lead Sponsor:
Reckitt Benckiser Healthcare (UK) Limited
Conditions:
Ejaculation Delayed
Eligibility:
MALE
18-60 years
Phase:
NA
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 ejac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05255770
Start Date
April 1 2022
End Date
January 1 2023
Last Update
September 16 2022
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