Study to determine the correlation between condom breakage in human use and laboratory test results.

The present study examined the value of laboratory tests in predicting condom breakage for 20 lots of latex condoms which differed in age, storage history and laboratory test performance. Two-hundred-sixty-two participating U.S. couples used a total of 4589 latex condoms (mean = 229 condoms per lot, range 224-235). Breakage rates ranged from 3.5 percent for a brand new condom lot to 18.6 percent for a lot that was 81 months old at the time of the study. The statistical predictor models, separately using ultimate elongation from the tensile test, the Condom Quality Index from the airburst volume test, and the percent of condoms failing the airburst volume test as the independent variables and the condom breakage rate as the dependent variable, all appear to have a high level of accuracy in predicting condom breakage in use. The three models had correlation coefficients (R2s) of 0.81, 0.74 and 0.69, respectively. Perhaps the most unexpected result was that the age of the condom lot was the best predictor of condom breakage during use (correlation coefficient (R2) = 0.92). Although the present investigation does not provide sufficient justification to use age as the only factor for decisions on condom lot disposition, it does provide some guidance.

RCT Entities:   Population Interventions Outcomes