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

NCT ID: NCT05840172

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2024-10-07

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.

Detailed Description

In this 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 ejaculation in healthy adult men who feel they ejaculate too quickly during vaginal sex.

Conditions

Ejaculation Delayed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Control NRL condom

Intervention Type: DEVICE

IIn 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.

Interventions

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

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.

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Control NRL condom

IIn 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects and their female partners have provided written informed consent.

2. Subjects and their female partners between the ages of >= 18 years and =< 60 years.

3. Subjects and their female partners must have no health condition in their medical history.

4. Subject must be sexually active having regular intercourse.

5. Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.

6. Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.

7. Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale.

Exclusion Criteria

1. Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation.

2. Subject or his female partner with a current history of alcohol or drug abuse.

3. 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.

4. 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.

5. 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:

1. urological disease,

2. ongoing significant psychiatric disorder not controlled by medication

3. history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra

4. relevant previous or planned genital surgery

5. female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness)

6. any broken skin or wounds in the genital area.

6. Subjects on medication that is contraindicated, which may affect erection.

7. 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.

8. Subject and/or his female partner is using or intends to continue to use antibiotics of the sulphonamide type.

9. 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.

10. Subject that has been diagnosed or received treatment for PE (premature ejaculation).

11. Subjects with confirmed erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia.

12. Confirmed diagnosis of male subjects with other forms of ejaculatory dysfunction.

13. Subjects that have had prior genital, prostatic or lower tract surgery.

14. Subjects with haemorrhagic disorder, hepatitis B or C, HIV infection or having had penile implant surgery, at any time in their past.

15. Either partner needed to use condoms for a specific STI protection.

16. Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirstin Deuble-Bente, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

SGS proderm GmbH

Locations

SGS proderm GmbH

Hamburg, , Germany

Countries

Germany

Other Identifiers

5078401

Identifier Type: -

Identifier Source: org_study_id