Effect of Nonoxynol-9 Gel on Urogenital Gonorrhea and Chlamydial Infection: A Randomized Controlled Trial

Abstract

There is conflicting information concerning the protection afforded by contraceptive spermicides against sexually transmitted disease (STD). The aim of this study was to compare the use of a spermicidal gel, nonoxynol-9, and condoms with condom use alone for the prevention of genitourinary gonorrhea and chlamydial infection in females. Participants in the study were sexually active women who were not sex workers; they were recruited from 10 clinics and 10 pharmacies in Yaounde, Cameroon, over a 2-year period. Only women at high risk for gonorrhea and chlamydial infection, that is, women who had a recent history of symptoms of STD and who engaged in coitus at least once a week, were considered for enrollment. Every effort was made to ensure that participants were fully informed of the nature and requirements of the study. Referees went through an initial screening/consent process at the clinic. Women who had a curable STD at this time were treated and offered rescreening before study participation. Women with no infection entered the trial within 30 days. Before randomization, women underwent extensive counseling to maximize compliance with the study protocols; they were then randomly assigned to either the gel and condom group or the condom alone group. Follow-up consisted of monthly visits to the pharmacy for 6 months with referral to a clinic for symptoms of STD infection. Condom and gel use was established by interview. Women continued in the study until they were diagnosed with Neissera gonorrhoeae or Chlamydia trachomatis or until they became positive for HIV. The clinical and demographic characteristics of each group were similar. Participants were generally well educated and remained consistent in sexual activity (average, three coital acts per week). For women in the gel group, condom use was reported for 81% of coital acts, gel use for 76%, both gel and condom use for 67%, gel only use for 13%, and no condom or gel for 5.6% of coital acts. Those in the condom-only group reported condom use 87% of the time. The condom broke or slipped off with equal frequency in both groups, approximately 4.5% of the time. Using spermicidal gel had no effect on the number of new urogenital infections diagnosed. In fact, the women using both condoms and gel had a 1.2% higher rate of STD infection than those who used condoms alone. The rate of referral to the clinic for symptoms of urogenital infection was equal for both groups. Five women using condoms and gel and four using condoms only converted to HIV seropositive during follow-up. Three women in each group became pregnant while participating in the study. Bacterial vaginosis, yeast infections, trichomoniasis, pelvic inflammatory disease, and genital ulcers were diagnosed with equal frequency in both groups during the follow-up period.