Sildenafil citrate (Viagra®) in the treatment of men with erectile dysfunction in southern Latin America:: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study

Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra((R))) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America, and (2) to correlate Rigiscan((R)) measurements assessing ED etiology with the investigator's assessment. A total of 141 men with broad-spectrum ED (mean age 57) were enrolled in a randomized, 12-week, double-blind, placebo-controlled, flexible-dose escalation study of sildenafil. After the 12-week treatment period, the mean score for the primary efficacy variables had risen significantly: for the sildenafil group, 66.2% from baseline for question 3 of the International Index of Erectile Function and 77.6% for question 4, vs 15.1% and 21.2% for the placebo group, respectively (P < 0.0001). Rigiscan((R)) data confirmed investigator assessments of etiology. Headache and flushing, usually mild and transient, were the most common adverse events. Sildenafil was an effective, well-tolerated treatment for men in southern Latin America with broad-spectrum ED.