Safety of a nonoxynol-9 vaginal gel in Kenyan prostitutes. A randomized clinical trial.
OBJECTIVE
To evaluate the safety and toxicity of once-daily administration of Advantage-24 (Columbia Research Laboratories, Inc., Rockville Centre, NY), a vaginal gel containing 52.5 mg of nonoxynol-9 (N-9), including the effects of this gel on the vaginal and cervical epithelium.


METHODS
Randomized, placebo-controlled, double-blind crossover trial, with a 2-week product application period and a 2-week washout period.


METHODS
Female sex workers in Mombasa, Kenya were randomized to one of two sequences, N-9 followed by placebo, or vice versa. Women were instructed to apply one applicator of N-9 or placebo gel vaginally once each day. During each of the two product periods, subjects were evaluated by questionnaire and physical examination, including colposcopy, after 7 and 14 days of product use. The primary outcome was genital epithelial disruption.


RESULTS
Sixty subjects were randomized, of whom 52 (87%) had complete follow-up. There were four episodes of epithelial disruption, three of which occurred during the placebo period and one during the N-9 period. The estimated risk of epithelial disruption associated with N-9 use was 0.33 (95% confidence interval, 0.03-3.26). There was no increased frequency of other, nondisruptive epithelial lesions during N-9 use.


CONCLUSIONS
No genital epithelial toxicity of N-9 vaginal gel was observed. This safety profile suggests that this N-9 product is appropriate for evaluation for human immunodeficiency virus type 1 prevention in a phase III efficacy trial.
Martin
H L
HL
Department of Medicine, University of Washington, Seattle 98104-2499, USA.
Stevens
C E
CE
Richardson
B A
BA
Rugamba
D
D
Nyange
P M
PM
Mandaliya
K
K
Ndinya-Achola
J
J
Kreiss
J K
JK
D000328:Adult; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D007630:Kenya; D009092:Mucous Membrane / Q000187:drug effects / Q000473:pathology; D017137:Nonoxynol / Q000008:administration & dosage* / Q000009:adverse effects; D011477:Sex Work; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D013089:Spermatocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014621:Vagina / Q000187:drug effects* / Q000473:pathology
D005782:Gels; D013089:Spermatocidal Agents; D017137:Nonoxynol