NCT06595836

Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom

Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Thai Nippon Rubber Industry Public Company Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.

Detailed description

Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom. The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.

Conditions

• Condom Use

Interventions

Type	Name	Description
DEVICE	Silicone Lubricated Synthetic polyisoprine condom	Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
DEVICE	Silicone Lubricated Natural Rubber Latex Condom	Natural rubber latex condoms are made from natural rubber

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study