Status:
UNKNOWN
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Pfizer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
35-70 years
Phase:
PHASE4
Brief 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...
Detailed Description
This will be a prospective, placebo-controlled, double blind crossover study. One hundred males between 35-70 years of age in good general health will be included. Recruitment of patients will be done...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00313898
Start Date
September 1 2005
End Date
June 1 2007
Last Update
May 17 2007
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel, 31096