Mild To Moderate Erectile Dysfunction Study

Phase 4

Completed

• Conditions: Impotence

• Registration Number: NCT00137072
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-29
• Study Completion: 2006-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 355

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
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Spokane, Washington, United States