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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141349
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : July 25, 2006
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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.

Condition or disease Intervention/treatment Phase
Impotence Drug: UK-369,003 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141349

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer Identifier: NCT00141349     History of Changes
Other Study ID Numbers: A3711029
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: July 25, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders