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A Randomized Controlled Trial

Ronald E. Roddy, MPH; Léopold Zekeng, PhD; Kelley A. Ryan, BA; Ubald Tamoufé, MSc; Kathryn G. Tweedy, MSc

JAMA. 2002;287:1117-1122.

Context  Nonoxynol-9 has been suggested as a vaginal microbicide to protect against common sexually transmitted infections.

Objective  To compare nonoxynol-9 gel and condom use (gel group) vs condom use alone (condom group) for the prevention of male-to-female transmission of urogenital gonococcal and chlamydial infection.

Design and Setting  Randomized controlled trial conducted at 10 community clinics and 10 pharmacies in Yaoundé, Cameroon, between October 1998 and September 2000, with 6 months of follow-up.

Participants  High-risk population of 1251 women (excluding sex workers) being treated for or who had symptoms of sexually transmitted infections. Three were excluded from the gel group (0.5%) and 7 from the condom group (1%) because of no follow-up data.

Interventions  Nonoxynol-9 gel (100 mg) and condoms or condoms only.

Main Outcome Measure  A positive test result for gonococcal or chlamydial infection by the ligase chain reaction assay; secondary outcome measure was a positive test result for human immunodeficiency virus (HIV).

Results  The rate ratio (RR) for new urogenital infections was 1.2 for the gel group vs condom group (95% confidence interval [CI], 0.9-1.6; P = .21). The gel group had 116 diagnosed gonococcal infections, chlamydial infections, or both for a rate of 43.6 per 100 person-years, and the condom group had 100 infections for a rate of 36.6 per 100 person-years. The RR for gonococcal infection in the gel group vs the condom group was 1.5 (95% CI, 1.0-2.3) and for chlamydial infection was 1.0 (95% CI, 0.7-1.4). There were 5 new cases of HIV infections in the gel group and 4 in the condom group. Three women in each group became pregnant during the study.

Conclusion  Nonoxynol-9 gel did not protect against urogenital gonococcal or chlamydial infection.

Author Affiliations: Family Health International, Durham, NC (Mr Roddy and Mss Ryan and Tweedy); Laboratoire de Santé Hygiène Mobile, Ministry of Public Health (Dr Zekeng), and Care and Health Program (Mr Tamoufé), Yaoundé, Cameroon.

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