Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

Sexually Transmitted Diseases Clinical Trial

Official title: A Functional Performance and Acceptability Evaluation of Synthetic Nitrile Male Condom Compared to a Standard Latex Male Condom

Status Recruiting

Clinical Trial Summary

Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.

Clinical Trial Description

A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom. Each couple will be asked to use five synthetic nitrile condoms, and five latex control male condoms 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 two follow-up visits conducted after using each set of five condoms. The trial will enrol up to 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. ;

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

• NCT number: NCT06079060
• Study type: Interventional
• Source: Karex Industries Sdn. Bhd.
• Contact: Mags Beksinska, PhD
• Phone: +27-310011916
• Email: mbeksinska@mru.ac.za
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Completion date: June 2024