Evaluation of a low-dose nonoxynol-9 gel for the prevention of sexually transmitted diseases: a randomized clinical trial.

Abstract

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).

GOAL:

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.

STUDY DESIGN:

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.

• Authors: B A Richardson, L Lavreys, H L Martin Jr, C E Stevens, E Ngugi, K Mandaliya, J Bwayo, J Ndinya-Achola, J K Kreiss
• Journal: Sexually transmitted diseases (Sex Transm Dis) Vol. 28 Issue 7 Pg. 394-400 (Jul 2001) ISSN: 0148-5717 [Print] United States
• PMID: 11460023 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Gels
• Surface-Active Agents
• Vaginal Creams, Foams, and Jellies
• Nonoxynol

Topics

• Administration, Intravaginal
• Adolescent
• Adult
• Double-Blind Method
• Erythema (chemically induced)
• Female
• Follow-Up Studies
• Gels
• Humans
• Incidence
• Kenya (epidemiology)
• Middle Aged
• Nonoxynol (adverse effects, therapeutic use)
• Sex Work (statistics & numerical data)
• Sexually Transmitted Diseases (diagnosis, epidemiology, microbiology, prevention & control)
• Surface-Active Agents (adverse effects, therapeutic use)
• Vaginal Creams, Foams, and Jellies
• Vaginal Diseases (chemically induced)