Status:
COMPLETED
A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT00648596
Start Date
May 1 2003
End Date
May 1 2004
Last Update
February 1 2021
Active Locations (66)
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1
Pfizer Investigational Site
Oulu, Finland, 90100
2
Pfizer Investigational Site
Tampere, Finland
3
Pfizer Investigational Site
Turku, Finland, 20110
4
Pfizer Investigational Site
Clermont-Ferrand, France, 63023