Methods | Random allocation in order of study entry, based on table of random numbers. Open label study. No placebos were used. |
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Participants | 168 women with trichomoniasis from Brooklyn, Charlottesville, and Baltimore, USA. Patients were advised to use condoms to prevent reinfection and to refer partners for treatment. Exclusion criteria: pregnancy or suspected pregnancy, hypersensitivity to imidazoles, central nervous system (CNS) disease, severe hepatic disease, blood dyscrasias, using oral anticoagulants, treatment for trichomoniasis in preceding 4 weeks, inability to complete treatment between menstrual periods. |
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Interventions | Metronidazole 2 g by mouth single dose versus two 100 mg clotrimazole vaginal tablets once a day for 7 days versus AVC vaginal suppository (containing 1.05 g sulfanilamide, 14 mg aminacrine hydrochloride, and 140 mg allantoin) twice a day for 7 days. | |
Outcomes | Parasitological and clinical cure. Side effects. | |
Notes | Diagnosis by smear, culture, and symptomatic score. Follow up 2‐3 and 4‐6 weeks after treatment. Patients dropped from the study were replaced with patients who received the same treatment. Exclusion from analysis (35 women): failure to return for first follow up visit (19), invalid spacing of visits (5), discontinuance of drug because of adverse reactions (2), other protocol violations (9). 168 women enrolled, 133 (79%) evaluable for efficacy. |