NCT05912283

Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Karex Industries Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

Detailed description

A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.

Conditions

• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DEVICE	Synthetic Nitrile Condoms (53mm)	53mm width synthetic nitrile condoms
DEVICE	Synthetic Nitrile Condoms (56mm)	56mm width synthetic nitrile condoms
DEVICE	Control Latex Condom	Commercial natural rubber latex condom

Timeline

• Start date: 2023-06-02
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-06-22
• Last updated: 2024-05-28

Locations

3 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated device study