Assessment of a new modified soft jelly capsule containing nonoxynol as spermicide contraceptive

The mean rupture time, after its vaginal insertion, of a new modified soft jelly capsule containing nonoxynol-9 (DF-486) was investigated in 40 women. The subjects were randomly allocated to 8 study groups. The capsules remained in the vagina from 2-13 minutes. Vaginal infection, vaginal dryness, and multiparity, were recorded. Capsule rupture was not observed at minute 2; 20% of capsules that remained in the vagina 3 minutes suffered rupture, as did 80% of capsules that remained 4, 5 and 7 minutes, and 100% of those remaining 9 minutes or more. The mean rupture time of the studied capsules was 8.2 minutes with 95% confidence limits of 6.2 and 8.8 minutes. At minutes 2-7, vaginal infection, dryness and tone diminution probably accounted for lack of rupture; after minute 7, these factors did not influence capsule rupture.