Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

In clinical practice it is quite common to have sexually active male patients with mild/normal erectile function that are not satisfied with their sexual function. The aim of this study is to evaluate the effect of sildenafil on the quality of sexual function in this group of patients.

The endpoint of this study is to define another, different group of patients that may respond positively to treatment with sildenafil.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Pfizer
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Sexually active males.

• All males between 35-70 years of age that previously have not taken any PDE5 inhibitors.

• A score of 22/30 and above of the International Index of Erectile Function (IIEF) ED domain (questions 1,2,3,4,5,15) .

Exclusion criteria:

• Patients with psychiatric disorders

• Patients with contraindications to sildenafil (patients on nitrate prescription, very low blood pressure, multiple anti-hypertensive medications, allergy to PDE5i, severe renal or hepatic insufficiency etc)

• Patients with a severe coronary artery disease

• Patients with premature ejaculation as their primary problem without a current partner.