Effect of nonoxynol-9 gel on urogenital gonorrhea and chlamydial infection: a randomized controlled trial.
BACKGROUND
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.


METHODS
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.


METHODS
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.


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


METHODS
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.


CONCLUSIONS
Nonoxynol-9 gel did not protect against urogenital gonococcal or chlamydial infection.
Roddy
Ronald E
RE
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA. rroddy@fhi.org
Zekeng
Léopold
L
Ryan
Kelley A
KA
Tamoufé
Ubald
U
Tweedy
Kathryn G
KG
D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis / Q000517:prevention & control*; D017280:Condoms; D005260:Female; D005782:Gels; D006069:Gonorrhea / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D017137:Nonoxynol / Q000627:therapeutic use*; D015231:Sexually Transmitted Diseases, Bacterial / Q000517:prevention & control; D013089:Spermatocidal Agents / Q000627:therapeutic use*; D013501:Surface-Active Agents / Q000627:therapeutic use*
D005782:Gels; D013089:Spermatocidal Agents; D013501:Surface-Active Agents; D017137:Nonoxynol