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N/A Completed N=150 Randomized Other

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

Ejaculation Delayed
Source: ClinicalTrials.gov NCT05840172 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation — 168.40; 104.46 Seconds

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
To Determine the Effectiveness of Benzocaine of the Test Condom A Compared With the Control NRL Condom at Prolonging Time to Ejaculation
168.40; 104.46
SECONDARY
To Determine the Effectiveness of Benzocaine of the Test Condom B Compared With the Control NRL Condom at Prolonging Time to Ejaculation
124.96; 104.46
SECONDARY
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
1.58; 1.36; 1.72; 1.25; 1.65; 1.22
SECONDARY
To Evaluate the Sexual Pleasure When Using the Test Condom A or Test Condom B Compared With the Control NRL Condom
69.93; 69.67; 68.93
SECONDARY
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
5; 3; 4; 12; 6; 5
SECONDARY
Participant - Subject Perceived Questionnaire (SPQ)
4; 5; 4; 6; 7; 10
SECONDARY
Total Clinical Failure Rate of Each Type of Condoms
2.0; 1.4; 0.6
SECONDARY
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Male Participants
0; 0; 0; 1; 0; 0
SECONDARY
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AE/ADEs) - Female Participants
0; 0; 0; 1; 0; 0

Eligibility Criteria

Main Inclusion Criteria:

  • Subjects and their female partners have provided written informed consent.
  • Subjects and their female partners between the ages of >= 18 years and =< 60 years.
  • Subjects and their female partners must have no health condition in their medical history.
  • Subject must be sexually active having regular intercourse.
  • Subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months.
  • Subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal.
  • Subjects reporting a frequency of 'occasionally' to the Sexual Intercourse Self-Estimation Scale.

Main Exclusion Criteria:

  • Subject with a pregnant or breastfeeding female partner or the female partner desires to become pregnant during the clinical investigation.
  • Subject or his female partner with a current history of alcohol or drug abuse.
  • 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.
  • 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.
  • 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:
  • urological disease,
  • ongoing significant psychiatric disorder not controlled by medication
  • history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra
  • relevant previous or planned genital surgery
  • female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness)
  • any broken skin or wounds in the genital area.
  • Subjects on medication that is contraindicated, which may affect erection.
  • 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.
  • Subject and/or his female partner is using or intends to continue to use antibiotics of the sulphonamide type.
  • 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.
  • Subject that has been diagnosed or received treatment for PE (premature ejaculation).
  • Subjects with confirmed erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia.
  • Confirmed diagnosis of male subjects with other forms of ejaculatory dysfunction.
  • Subjects that have had prior genital, prostatic or lower tract surgery.
  • Subjects with haemorrhagic disorder, hepatitis B or C, HIV infection or having had penile implant surgery, at any time in their past.
  • Either partner needed to use condoms for a specific STI protection.
  • Subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, PABA, commercial hair dyes, paraphenylenediamine, lubricants and latex.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05840172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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