[Contraceptive efficacy of Sino-female condom: comparison with condom].
OBJECTIVE
To compare the contraceptive efficacy of Sino-female condom with condom.


METHODS
603 volunteer couples were randomly divided into two groups: 304 couples using female condom for contraception, and 299 using condom. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups.


RESULTS
No abnormal findings of cervical and vaginal smears were detected before and after this clinical trial in all 603 women. The follow-up rates at 6 months were 99.01% and 99.67% in the female condom group and condom group, respectively. The 6-month gross cumulative pregnancy rates were 1.06 and 1.69 per 100 women and the discontinuation rates due to allergy were 1.39 and 0.34, respectively. No difference was statistically significant (P > 0.05). However, the discontinuation rate for other causes in the female condom group was significantly higher than that in the condom group (P < 0.01). The main cause was that more than half of subjects were used to applying condom before this study.


CONCLUSIONS
The contraceptive efficacy of Sino-female condom is as same as that of condom, and its clinical use is quite safe.
Shanghai Municipal Family Planning Commission, Shanghai 200002.
J
J
Xu
Y
Y
Wu
Q
Q
Cao
D000328:Adult; D017280:Condoms; D019111:Single-Use Internal Condom; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged