Evaluating benzocaine in condoms for men with premature ejaculation

An Open Label, Randomised, 3-way Cross-over, Single-centre, Clinical Investigation 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

This study is testing if condoms with benzocaine can help men who ejaculate too quickly during sex last longer compared to regular condoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited (Industry-sponsored)
• Locations: 1 site (Hamburg)
• Trial ID: NCT05840172 on ClinicalTrials.gov

What this trial studies

This investigation assesses the effectiveness of two types of NRL condoms containing benzocaine in prolonging time to ejaculation compared to a standard NRL condom without benzocaine. Healthy adult men who feel they ejaculate too quickly during vaginal sex will participate in the study. Participants will use either a condom with 5% benzocaine, one with 3% benzocaine, or a control condom, and their experiences will be evaluated. The study aims to determine if these benzocaine-infused condoms can help improve sexual performance.

Who should consider this trial

Good fit: Ideal candidates are healthy adult men aged 18 to 60 who are sexually active and in a stable, monogamous relationship.

Not a fit: Patients with pregnant or breastfeeding partners, or those with a history of substance abuse, may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a non-invasive option for men experiencing premature ejaculation, enhancing their sexual experience.

How similar studies have performed: While similar approaches have been explored, this specific use of benzocaine in condoms is relatively novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Hamburg

• SGS proderm GmbH — Hamburg, Germany (Recruiting)

Study contacts

• Principal investigator: Kirstin Deuble-Bente, Medical Doctor — SGS proderm GmbH
• Study coordinator: Britta Baden

Conditions Ejaculation Delayed