Statistical analysis of breakage and slippage risk in a new condom

SSL International plc, manufacturers of Durex, developed a condom made from a new form of synthetic rubber, and wished to gain approval from the US Federal Drugs Administration (FDA) in order to bring it to market.

This necessitated a trial of the condom in which 200 couples were recruited to a clinical trial that involved the use of 5 of the new condoms and 5 more traditional condoms in order to make comparisons on such indices as breakage rate, slippage rate, and levels of sensitivity and of satisfaction. Various other relevant data were also obtained, such as position, use of jewellry etc.

The Psychometrics Centre was able to advise on the construction of the questionnaires on such a sensitive topic, and also to carry out the statistical analysis to the level required by the FDA. The key endpoints were comparisons between breakage and slippage rates of the two condoms using non-inferiority analysis and other maximum likelihood non-parametric procedures.

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