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This open-label, dose-escalation study investigated the ef®cacy and safety of alprostadil (PGE 1 , prostaglandin E 1 ) Sterile Powder (S.Po.) (Caverject # ) for treatment of erectile dysfunction (ED) in 84 men with ED of various etiologies lasting ! 4 months. Doses started with 2.5 mg, then 5 mg, 10, 15, 20, 30, up to a 40 mg maximum. Eligible patients received single alprostadil injections in the physician's of®ce until an erection occurred. Ten minutes after injection, the patient's erection was clinically evaluated. Optimal response was de®ned as erection suf®cient to permit vaginal penetration and lasting 30±60 min. The patient also reported his own evaluation of response and any side effects. Patients were 24±65 y old (mean: 43.7 y), had ED of psychogenic, vascular, or neurogenic origin lasting 4 months±30 y (mean: 3.75 y). Of 84 patients enrolled, 82 completed the study. In the 82 patients who completed the study 78 (92.9%) achieved an optimal response; 18/78 patients (23.1%) had an optimal response at 2.5 mg, 9/78 (11.5%) at 5 mg, 21/78 (26.9%) at 10 mg, 12/ 78 (15.4%) at 15 mg, and 11/78 (14.1%) at 20 mg. Only 5/78 (6.4%) at 30 mg and 2/78 (2.6%) at 40 mg achieved an optimal response. Mean optimal alprostadil dose was 11.9 mg, and the mean minimal effective dose was 9.9 mg. Mean onset of erection was 11.2 min; mean duration of erection was 50.5 min. Penile pain in ®ve patients (6%) was the only reported side effect.