Evaluation of a low-dose nonoxynol-9 gel for the prevention of sexually transmitted diseases: a randomized clinical trial.
BACKGROUND
Low-dose nonoxynol-9 products have a potential advantage of reduced toxicity. However, little is known about their efficacy in reducing the incidence of sexually transmitted diseases (STDs).


OBJECTIVE
To determine the effect that an intravaginal gel containing 52.5 mg of nonoxynol-9 has on the acquisition of STDs in a cohort of HIV-1-seronegative female sex workers in Mombasa, Kenya.


METHODS
A randomized double-blind placebo controlled trial was performed.


RESULTS
In this study, 139 women were randomized to the nonoxynol-9 group and 139 to the placebo group. No significant differences were found between the two study groups in terms of safety outcomes and reported symptoms, except for a lower incidence of vaginal erythema in the nonoxynol-9 group. There was a significantly higher incidence of gonorrhea in the nonoxynol-9 group than in the placebo group. No significant differences were observed between the groups for acquisition of Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1, although the statistical power to detect differences for some of these STDs was limited.


CONCLUSIONS
In this randomized placebo-controlled trial of a low-dose nonoxynol-9 gel, a significantly higher incidence of gonorrhea was found in the nonoxynol-9 group, but no significant differences between the groups were found for Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1.
Richardson
B A
BA
Departments of Biostatistics, Epidemiology, and Medicine, University of Washington, Seattle WA 98104-2499, USA.
Lavreys
L
L
Martin
H L
HL
Stevens
C E
CE
Ngugi
E
E
Mandaliya
K
K
Bwayo
J
J
Ndinya-Achola
J
J
Kreiss
J K
JK
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D015994:Incidence; D007630:Kenya / Q000453:epidemiology; D008875:Middle Aged; D017137:Nonoxynol / Q000009:adverse effects / Q000627:therapeutic use*; D011477:Sex Work / Q000706:statistics & numerical data; D012749:Sexually Transmitted Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D013501:Surface-Active Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014622:Vaginal Creams, Foams, and Jellies; D014623:Vaginal Diseases / Q000139:chemically induced
D005782:Gels; D013501:Surface-Active Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol