NCT06079060

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Karex Industries Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DEVICE	Synthetic Nitrile Condom (61mm)	61mm width Synthetic Nitrile Condoms
DEVICE	Control Latex Condom	61mm width Natural Rubber Latex Condom

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-09-30
• Completion: 2024-10-11
• First posted: 2023-10-12
• Last updated: 2025-10-24

Locations

3 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated device study