NCT03739190

A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples

A 3-way Cross-over, Multi-centre Clinical Investigation to Evaluate the Performance Rate of Natural Rubber Latex Condoms of Varying Thickness in Healthy Monogamous Couples

• 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 new natural rubber latex (NRL) male condom.

Detailed description

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

Conditions

• Control of Pregnancy
• Prevention of Sexually Transmitted Infections

Interventions

Type	Name	Description
DEVICE	NRL Condom	A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.

Timeline

• Start date: 2019-07-22
• Primary completion: 2019-12-27
• Completion: 2019-12-27
• First posted: 2018-11-13
• Last updated: 2020-03-12

Locations

1 site across 1 country: Thailand