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• W2070223721 abstract "Forty-nine mutually monogamous couples used a total of 478 condoms during vaginal intercourse in a prospective trial whose purpose was to discover whether the performance of a new non-latex hypoallergenic condom was substantially equivalent to that of a leading condom brand already being marketed. Of these 478 condoms, seven (1.46%) either broke or fell off the penis during intercourse. Two (0.42%) of the 471 condoms that did not break or fall off during intercourse fell off the penis when it was being withdrawn from the vagina. Altogether, 469 (98.1%) of the 478 condoms used for intercourse survived intact throughout intercourse and withdrawal. Differences in breakage and slippage rates for the two condom brands were statistically insignificant. The overall 98.1% success rate is much higher than the rate of success found in a previous condom trial with nearly identical research protocol. The reason for the difference is attributed to much more precise questioning of subjects in the current trial.This comparative study of the Tactylon condom and the Trojan-Enz condom was conducted in order to obtain FDA market approval. 50 female subjects were recruited through public notices for hospital and university personnel. The requirements were that female subjects must be between the ages of 18-55, fertile and not presently using another contraceptive, and not at risk for or have a significant medical history of sexually transmitted disease. Male partners were also to be in good health and currently not using another form of contraception. Couples were to use condoms in 10 acts of intercourse over a 5-week period without a lubricant. Each couple received 5 of each kind of condom and 10 questionnaires, each numbered sequentially from 1 to 10. Condoms and questionnaires were to be used in sequential order beginning with 1. Half the couples started with the Tactylon condom and the other half with Trojan-Enz. Demonstrations and instruction were given for use. Caution is advised in interpreting breakage rates due to the small sample sizes (250 for each brand). 49 of the subject completed the study. 82% were black and 18% were whites, non-Hispanic. 45% were married, 24% single, 27% were divorced, and 4% separated. 14% were nulliparous, 27% with 1 child, 37% with 2 children, and 22% with 3 children. 37% reported incomes of 20,000 or 35,000. The mean age was 34.4 for females and 37.2 for males. 84% of males were circumcised. The average monthly number of acts of intercourse was 14.5 and yearly 147.2. Condoms were used in this study similar to past behavior, with 10 condoms used in 21 days. 45% had not used condoms in the preceding month, and 16% in the preceding year. 10% had never used condoms in their relationship. The average use of condoms for those using in the past month was 7.8. The average breaking rate per condom for those who used condoms in the prior month was 6.2%, and in the prior year 5.0%. The breakage and slippage rates were high. Conditions for breakage and slippage were defined and clearly recorded. Evaluation for pleasure was requested of each party. The results were that breakage and slippage rates were similar for the 2 condoms, and lower than prior use and unrelated to use of a lubricant or prior use conditions. The frequency of slippage necessitates further research. The falling off rate of 3 in 472 condoms was not statistically different from retrospective rates of users. Prior trial rates were higher perhaps due to the condoms being lubricated, or the changed wording on the questionnaire to differentiate falling off. The subject's evaluations of condoms were also similar for both condoms." @default.
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• W2070223721 date "1992-01-01" @default.
• W2070223721 modified "2023-09-25" @default.
• W2070223721 title "Condom performance during vaginal intercourse: Comparison of trojan-enz® and tactylonTM condoms" @default.
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• W2070223721 doi "https://doi.org/10.1016/0010-7824(92)90137-i" @default.
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