At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom
In Brief
A clinical study evaluating Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B for Contraception and Prevention of Sexually Transmitted Infections. Completed, enrolled 300 participants across 1 site.
Detailed Summary
The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.
Study Details
Timeline
Interventions
Condom functionality study to determine failure rates