Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
Phase 4
Completed
- Conditions
- Impotence
- Registration Number
- NCT00143260
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 250
Inclusion Criteria
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
Exclusion Criteria
- Subjects with penile implants
- Subjects with a known history of retinitis pigmentosa.
- Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
- Secondary Outcome Measures
Name Time Method Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Spokane, Washington, United States
Pfizer Investigational Site🇺🇸Spokane, Washington, United States