Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product

Abstract

Background ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity. Methods 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. Results 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, H 2O 2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles. Conclusions 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.