NCT00249730CompletedPhase 4
A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.39 sites in 8 countries510 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 510
- Locations
- 39
- Primary Endpoint
- Change in IIEF erectile function domain score at the end of double blind treatment.
Study Overview
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 double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤
- •Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in IIEF erectile function domain score at the end of double blind treatment.
Secondary Outcomes
- Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
Investigators
Study Sites (39)
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