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

Reckitt Benckiser

Status: Enrolling

Conditions: Ejaculation Delayed

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05840172

5078401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main 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.

Main 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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300 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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

Control NRL condom

Placebo Comparator group

Description:

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.

Treatment:

Device: Control NRL condom