A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

• Drug: sildenafil
  
  sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
• Drug: placebo
  
  placebo tablet by mouth 1 hour before sexual activity for 12 weeks

• Placebo Comparator: Arm 2
  
  Intervention: Drug: placebo
• Active Comparator: Arm 1
  
  Intervention: Drug: sildenafil

Inclusion Criteria:

-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.

Exclusion Criteria:

• Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months
• Subjects with resting sitting hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg)
• Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months
• Patients on nitrates.