Background: We report on the functional performance, safety and acceptability of the 90-mm Reddy female condom in two clinical trials, one in Los Angeles, CA, and one in Pune, Maharashtra, India.
Study design: Both studies used a Phase I, crossover design involving 25 couples. Each couple used three condoms of each of two shaft lengths: in Los Angeles, shaft lengths of 150 and 90 mm were used; in Pune, shaft lengths of 120 and 90 mm were used. This paper focuses on the 90-mm condom since it is commercially available. The primary endpoint of each study was invagination, defined as the outer frame of the condom being pushed into the vagina during intercourse. Secondary functionality endpoints included nonclinical breakage, clinical breakage, penile misdirection and complete slippage.
Results: Invagination occurred in 26.9% of uses in Los Angeles vs. 6.8% of uses in Pune. Penile misdirection and complete slippage were reported only in Pune during 4.0% and 9.5% of uses, respectively. There were two clinical breaks in Pune and none in Los Angeles. Total clinical failure was 26.9% in Los Angeles and 23.0% in Pune.
Conclusions: Two clinical studies of the 90-mm Reddy female condom suggest that its functional performance is inferior to other female condoms.
Copyright © 2011 Elsevier Inc. All rights reserved.