Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
Phase 4
Completed
- Conditions
- Impotence
- Registration Number
- NCT00245258
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The study objective is to:
1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase
2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 312
Inclusion Criteria
- Male subjects aged 18-65.
- Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)
Exclusion Criteria
- Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
- Secondary Outcome Measures
Name Time Method The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇪Stockholm, Sweden