NCT04134039

A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples

A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.

Detailed description

In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.

Conditions

• Control of Pregnancy
• Prevention of Sexually Transmitted Infections

Interventions

Type	Name	Description
DEVICE	Polyurethane (PU) condom	A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
DEVICE	Natural Rubber Latex (NRL) condom	A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.

Timeline

• Start date: 2021-02-09
• Primary completion: 2021-07-05
• Completion: 2021-07-05
• First posted: 2019-10-21
• Last updated: 2021-09-16

Locations

1 site across 1 country: Thailand