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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141349
First received: August 30, 2005
Last updated: July 23, 2006
Last verified: January 2006
History of Changes
  Purpose

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
Impotence
 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:

U.S. FDA Resources

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
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141349

  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov 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
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013