NCT05255770

A Clinical Investigation to Assess the Effectiveness of Benzocaine Condoms in Healthy Adult Men

A Double Masked, Randomised, 3-way Cross-over, Single-center, Clinical Investigation to Evaluate the Effectiveness of Two NRL Condoms With Benzocaine Paste Compared With a Standard NRL Control in Prolonging Time to Ejaculation in Healthy Adult Men

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This investigation is designed to evaluate the effectiveness of two NRL condoms with Benzocaine paste compared with a standard NRL control.

Detailed description

In this clinical 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.

Conditions

• Ejaculation Delayed

Interventions

Type	Name	Description
DEVICE	Test condom A (NRL condom with 5% benzocaine paste)	In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
DEVICE	Test condom B (NRL condom with 3% benzocaine paste)	In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.
DEVICE	Control NRL condom	In each assessment period (intervention duration), subjects will be provided with a condom type to use during vaginal intercourse and will report at least 4 duration records (from vaginal entry to ejaculation) over a 4-week period.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-02-25
• Last updated: 2022-09-16