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

Int J Impot Res. 2002 Aug:14 Suppl 2:S33-41. doi: 10.1038/sj.ijir.3900896.

Abstract

Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America; and (2) to correlate Rigiscan 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 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Erectile Dysfunction / drug therapy*
  • Humans
  • Latin America
  • Male
  • Middle Aged
  • Piperazines / administration & dosage*
  • Piperazines / adverse effects
  • Piperazines / therapeutic use
  • Placebos
  • Purines
  • Safety
  • Sildenafil Citrate
  • Sulfones
  • Treatment Outcome
  • Vasodilator Agents / administration & dosage*
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use

Substances

  • Piperazines
  • Placebos
  • Purines
  • Sulfones
  • Vasodilator Agents
  • Sildenafil Citrate