A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men
NCT ID: NCT05255770
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-04-30
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Test condom A (NRL condom with 5% benzocaine paste)
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.
Test condom A (NRL condom with 5% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Test condom B (NRL condom with 3% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Control NRL condom
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Test condom B (NRL condom with 3% benzocaine paste)
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.
Test condom A (NRL condom with 5% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Test condom B (NRL condom with 3% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Control NRL condom
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Control NRL condom
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.
Test condom A (NRL condom with 5% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Test condom B (NRL condom with 3% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Control NRL condom
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Interventions
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Test condom A (NRL condom with 5% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Test condom B (NRL condom with 3% benzocaine paste)
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Control NRL condom
In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
MALE
Yes
Sponsors
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Reckitt Benckiser Healthcare (UK) Limited
INDUSTRY
Responsible Party
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Other Identifiers
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5061901
Identifier Type: -
Identifier Source: org_study_id
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