Abstract | BACKGROUND: METHODS: This was a 2-period crossover, randomized, noninferiority trial. Couples in 2 sites in the United States were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use 4 male condoms in each period. The primary noninferiority end points were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods using the male condom without the ring as reference. Noninferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed. RESULTS: Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% confidence interval: -5.3% to 1.5%), thereby demonstrating noninferiority when used with the ring. There was no difference in safety between the 2 periods. DISCUSSION:
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Authors | Annalene Nel, Mariëtte Malherbe, Neliëtte van Niekerk, Mags Beksinska, Ross Greener, Jennifer Smit, Ron Frezieres, Terri Walsh |
Journal | Journal of acquired immune deficiency syndromes (1999)
(J Acquir Immune Defic Syndr)
Vol. 85
Issue 1
Pg. 51-57
(09 01 2020)
ISSN: 1944-7884 [Electronic] United States |
PMID | 32452969
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Condoms
- Contraceptive Devices, Female
- Cross-Over Studies
- Female
- Humans
- Male
- Silicones
- Young Adult
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