Artículos de revistas
Vaginal Safety After Use Of A Bioadhesive, Acid-buffering, Microbicidal Contraceptive Gel (acidform) And A 2% Nonoxynol-9 Product.
Registro en:
Contraception. v. 73, n. 5, p. 542-7, 2006-May.
0010-7824
10.1016/j.contraception.2005.12.006
16627043
Autor
Amaral, Eliana
Perdigao, Antero
Souza, Maria Helena
Mauck, Christine
Waller, Donald
Zaneveld, Lourens
Faundes, Anibal
Institución
Resumen
ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity. This was a Phase I blinded, randomized and crossover clinical study on two products, ACIDFORM and a commercial nonoxynol-9 (N-9) product (2%), evaluating their vaginal safety in 20 couples aged between 19 and 45 years. The women had regular menses, underwent previous tubal ligation, were not breast-feeding, had no vaginal sign and symptom and were in a stable partnership; both partners had no previous STI. Colposcopy, vaginal microbiology, inflammation markers and subject complaints were studied after coitus. Women were randomly assigned sequentially to receive ACIDFORM 0-30 min (0-30 min before intercourse), ACIDFORM 8-10 h (8-10 h before intercourse) or N-9 0-30 min after a control cycle. Mild/moderate vulvar irritation was observed in five postcoital test colposcopies, burning and pruritus were reported in six treated cycles and non-irritation-related symptoms were found in five cycles with different treatments. No difference in vaginal pH, Nugent scores, H2O2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles. ACIDFORM appears to be safe for clinical use once a day. There is a potential spermicidal-microbicidal role for ACIDFORM as a vaginal flora helper or as a vehicle for products, except N-9. 73 542-7