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

Last updated: August 28, 2024
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Control NRL condom

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

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

Clinical Study ID

NCT05840172
5078401
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 medicalhistory.

  4. Subject must be sexually active having regular intercourse.

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

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

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

Exclusion

Main Exclusion Criteria:

  1. Subject with a pregnant or breastfeeding female partner or the female partnerdesires 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 atincreased risk of methaemoglobinemia / complications related to ester anaestheticswhich could trigger methemoglobinemia.

  5. Subject and/or his female partner have a physical or psychological condition thatwould prevent them from following investigation procedures - including but notlimited to the following:

  6. urological disease,

  7. ongoing significant psychiatric disorder not controlled by medication

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

  9. relevant previous or planned genital surgery

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

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

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

  13. Subject and/or his female partner have any medication which may affect the safety ofthe subject, including but not limited to benzocaine drug interactions such ascholinesterase inhibitors.

  14. Subject and/or his female partner is using or intends to continue to use antibioticsof the sulphonamide type.

  15. 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 penileimplant surgery.

  16. Subject that has been diagnosed or received treatment for PE (prematureejaculation).

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

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

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

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

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

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

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Control NRL condom
Phase:
Study Start date:
October 19, 2023
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • SGS proderm GmbH

    Hamburg,
    Germany

    Active - Recruiting

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