PURPOSE: To compare trovafloxacin, a new quinolone antibiotic with enhanced activity against Neisseria gonorrhoeae, with ofloxacin as single- dose oral therapy for uncomplicated gonococcal urethritis or cervicitis. PATIENTS AND METHODS: In this multicenter, doubleblind trial, 625 patients (270 men, 355 women) with uncomplicated gonococcal urethritis or cervicitis received one 100-mg tablet of trovafloxacin or two 200-mg capsules of ofloxacin as a single dose under direct supervision. RESULTS: Single-dose oral therapy with trovafloxacin was equivalent both bacteriologically and clinically to ofloxacin. Among evaluable patients, N gonorrhoeae was eradicated in 99% of trovafloxacin recipients and in 98% of ofloxacin recipients. Each treatment was well tolerated; vaginitis was the most frequently observed side effect (4% trovafloxacin, 7% ofloxacin). CONCLUSION: Based on the results presented here, trovafloxacin is a promising agent for single-dose therapy of uncomplicated gonorrhea.