Niruthisard S, Roddy RE, Fortney JA, Chutivongse S; International Conference on AIDS.
Int Conf AIDS. 1991 Jun 16-21; 7: 317 (abstract no. W.C.3084).
The Thai Red Cross Society, Bangkok, Thailand
OBJECTIVE: To compare the irritation effects of 72 mg of nonoxynol-9 (N-9) with a placebo (vaginal lubricant) on the genital mucosa. METHODS: 343 women were enrolled in a single blinded, randomized, controlled trial comparing 186 women (917 person-weeks) using N-9 with 157 women (755 person-weeks) using a placebo for 9 weeks. All women were provided condoms and encouraged to use them. The women received a physical exam for signs of genital ulcers (GUL) and reported symptoms of genital irritation. RESULTS: The N-9 group was comparable with the placebo group in age, duration of employment, and number of sexual encounters. 16 of the N-9 users and 13 of the placebo users developed GUL (Rate Ratio=1.01, 95% CI:0.5-2.1). All of the N-9 users' GUL were located on the vulva while 1 and 2 women in the placebo group had GUL in the vagina and on the cervix, respectively. 13 of N-9 users and 7 of placebo users complained of symptoms of irritation (RR=1.5, CI:0.6-3.8). 9 of N-9 users and 3 of placebo users dropped out of the study because of symptoms thought to be related to the inserts (RR=2.5, CI:0.7-9.1). 5 of N-9 users and 4 of placebo users developed yeast infections (RR=1.03, CI:0.3-3.8). The analysis of rates by frequency of insert use will also be presented. DISCUSSION: Moderate N-9 use (up to 22 times per week) was not associated with a higher rate of genital ulcers or yeast infections. N-9 use was associated with a slightly higher rate of symptoms of irritation and a higher rate of drop out from the study.
Publication Types:
Keywords:
- Clinical Trials as Topic
- Condoms
- Double-Blind Method
- Female
- Humans
- Mucous Membrane
- Nonoxynol
- Placebos
- Vagina
Other ID:
UI: 102193164
From Meeting Abstracts