Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

Phase 2

Completed

• Conditions: Impotence

• Registration Number: NCT00141349
• Lead Sponsor: Pfizer

Brief Summary

To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study Completion: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2006-01
• Last Update Submitted: 2006-07-23
• Last Update Posted: 2006-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents

Exclusion Criteria

• Alpha blockers and Nitrates of any preparation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The time needed to obtain an erection hard enough to attempt sexual intercourse.

Secondary Outcome Measures

Name	Time	Method
Proportion of responders based on successful erections Based on erections hard enough for sexual intercourse 15, 45 and 60 minutes post dose Proportion of good responders based on successful erections International Index of Erectile Function

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States