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

NCT05255770 | Withdrawn

• 1 other identifier: 5061901
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ejaculation Delayed

Outcome Measures

Primary Outcomes (1)

• To determine the effectiveness of the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation.

  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.

  4 weeks for each assessment period (intervention duration)

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]

  19 weeks

Study Arms (3)

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

EXPERIMENTAL

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.

Device: Test condom A (NRL condom with 5% benzocaine paste); Device: Test condom B (NRL condom with 3% benzocaine paste); Device: Control NRL condom

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

EXPERIMENTAL

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.

Device: Test condom A (NRL condom with 5% benzocaine paste); Device: Test condom B (NRL condom with 3% benzocaine paste); Device: Control NRL condom

Control NRL condom

ACTIVE COMPARATOR

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.

Device: Test condom A (NRL condom with 5% benzocaine paste); Device: Test condom B (NRL condom with 3% benzocaine paste); Device: Control NRL condom

Interventions

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

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; Test condom A (NRL condom with 5% benzocaine paste); Test condom B (NRL condom with 3% benzocaine paste)

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

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; Test condom A (NRL condom with 5% benzocaine paste); Test condom B (NRL condom with 3% benzocaine paste)

Control NRL condom DEVICE

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; Test condom A (NRL condom with 5% benzocaine paste); Test condom B (NRL condom with 3% benzocaine paste)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Male subjects who will use male condoms for intravaginal intercourse.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

MeSH Terms

Conditions

Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each condom will be contained within an individual foil packet on which all branding will be masked. All the condom types will be masked in the same manner and identical secondary packaging boxes will be used.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The condom types will be tested in a 3-way cross-over design where subjects will be randomised to use each of the 3 condom types in a defined order, according to the randomisation schedule.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 25, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share