Status:
COMPLETED
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Impotence
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of dou...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
Exclusion
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00249730
Start Date
October 1 2005
Last Update
February 1 2021
Active Locations (39)
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1
Pfizer Investigational Site
Kitchener, Ontario, Canada
2
Pfizer Investigational Site
Sarnia, Ontario, Canada
3
Pfizer Investigational Site
Toronto, Ontario, Canada
4
Pfizer Investigational Site
Saint-Léonard, Quebec, Canada