Clinical trial NCT05840172: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ejaculation Delayed
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: To determine the effectiveness of benzocaine of the Test Condom A compared with the Control NRL Condom at prolonging time to ejaculation
timeFrame: 4 weeks for each assessment period (intervention duration)
Secondary outcomes:
measure: To determine the effectiveness of benzocaine of the Test Condom B compared with the Control NRL Condom at prolonging time to ejaculation
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: 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
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: To evaluate the sexual pleasure when using the Test Condom A or Test Condom B compared with the Control NRL Condom
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: 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
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: Subject's experience on the use of each type of condoms [Acceptability and In-Use Tolerability]
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: Total clinical failure rate of each type of condoms
timeFrame: 4 weeks for each assessment period (intervention duration)
measure: Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
timeFrame: 19 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: SGS proderm GmbH
Study officials:
affiliation: SGS proderm GmbH
name: Kirstin Deuble-Bente, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: