A Clinical Investigation to Assess the Effectiveness of Benzocaine in NRL Condoms in Healthy Adult Men Who Feel They Ejaculate Too Quickly During Vaginal Sex

NCT05840172 | Completed Results

• 1 other identifier: 5078401
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The investigation is to evaluate the effectiveness of benzocaine in two NRL condoms compared with a standard NRL control without benzocaine in prolonging time to ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.

Conditions

Ejaculation Delayed

Outcome Measures

Primary Outcomes (1)

• To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation

  Participants recorded the duration from vaginal entry to ejaculation for each condom use. The outcome was evaluated by the change from baseline with the Test Condom A compared to the Control NRL Condom, over a 4-week assessment period. This outcome was to measure the per participant's average IELT time per condom type. The Intravaginal Ejaculation Latency Time (IELT) is the duration from the start of vaginal entry (vaginal penetration into the female partner) until the start of intravaginal ejaculation (release of semen). It did not analyze all condom uses or sexual encounters as a unit, rather those were taken as an average per participant, in order to effectively run a Generalized Linear Mixed Model. This outcome measure data was collected and analyzed for 150 male participants.

  4 weeks for each assessment period (intervention duration)

Secondary Outcomes (8)

• To Determine the Effectiveness of Benzocaine 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 Benzocaine 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)

• Participant - Subject Perceived Questionnaire (SPQ)

  4 weeks for each assessment period (intervention duration)

Study Arms (3)

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

EXPERIMENTAL

Following randomization, 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)

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

EXPERIMENTAL

Following randomization, 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 B (NRL condom with 3% benzocaine paste)

Control NRL condom

PLACEBO COMPARATOR

Following randomization, 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: Control NRL condom

Interventions

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

In each assessment period, 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. Subjects will repeat the assessment period each to test all 3 condom types.

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

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

In each assessment period, 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. Subjects will repeat the assessment period each to test all 3 condom types.

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

Control NRL condom DEVICE

In each assessment period, 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. Subjects will repeat the assessment period each to test all 3 condom types.

Control NRL condom

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects and their female partners have provided written informed consent.
• 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.
• 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.
• Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale.

You may not qualify if:

• Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation.
• Subject or his female partner with a current history of alcohol or drug abuse.
• Subjects and their female partners with a history of or are suffering from anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease.
• Subjects and their female partners with a history of, suspected to have, or be at increased risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia.
• Subject and/or his female partner have a physical or psychological condition that would prevent them from following investigation procedures - including but not limited to the following:
• urological disease,
• 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 previous or planned genital surgery
• female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness)
• 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 cholinesterase inhibitors.
• Subject and/or his female partner is using or intends to continue to use antibiotics of the sulphonamide type.
• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

SGS proderm GmbH

Hamburg, Germany

Location

MeSH Terms

Conditions

Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Reckitt Benckiser Health Limited

ClinicalRequests@reckitt.com

+44 (0)1482 326151

Study Officials

• Kirstin Deuble-Bente, MD

  SGS proderm GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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: April 21, 2023
• First Posted: May 3, 2023
• Study Start: October 19, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)