The effect of Ofloxacin (OFLX) administrated orally at a dose of 600mg for 7 to 14 days in 57 patients with gonococcal and/or non gonococcal urethritis were investigated. The effect of OFLX on symptom, white blood cell count in urine or urethral discharge, volume of urethral discharge and bacteria was evaluated. Overall clinical efficacy was approximately 80%. We also analyzed the difficulty and problems encountered in drug evaluation studies on STD, comparing some reports published in Japan.