Synthetic Male Condom Slippage-Breakage Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05370196
Study type	Interventional
Source	Church & Dwight Company, Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 10, 2022
Completion date	May 12, 2023

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