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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 30, 2005
Last updated: July 23, 2006
Last verified: January 2006
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.

Condition Intervention Phase
Drug: UK-369,003
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject With Erectile Dysfunction

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The time needed to obtain an erection hard enough to attempt sexual intercourse.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: February 2005
Estimated Study Completion Date: August 2005

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00141349

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00141349     History of Changes
Other Study ID Numbers: A3711029 
Study First Received: August 30, 2005
Last Updated: July 23, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders processed this record on April 27, 2016