NCT05370196

Synthetic Male Condom Slippage-Breakage Study

Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.

Detailed description

Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.

Conditions

• Contraceptive
• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DEVICE	Test Product	Synthetic Male Condom
DEVICE	Control Product	Latex Male Condom

Timeline

• Start date: 2022-06-10
• Primary completion: 2023-01-13
• Completion: 2023-05-12
• First posted: 2022-05-11
• Last updated: 2023-11-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study