Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product.
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, H2O2-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.
Amaral
Eliana
E
Obstetrics and Gynecology Department, UNICAMP, P.O. Box 6181, 13084-971 Campinas, SP, Brazil. elianaa@unicamp.br
Perdigao
Antero
A
Souza
Maria Helena
MH
Mauck
Christine
C
Waller
Donald
D
Zaneveld
Lourens
L
Faundes
Anibal
A
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000009:adverse effects; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D017137:Nonoxynol / Q000009:adverse effects*; D013089:Spermatocidal Agents / Q000009:adverse effects*; D014621:Vagina / Q000187:drug effects* / Q000382:microbiology
D000891:Anti-Infective Agents, Local; D013089:Spermatocidal Agents; D017137:Nonoxynol