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Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 12, 2005
Last updated: July 23, 2006
Last verified: November 2005
Assessment of duration of action, safety & toleration of different formulations and doses of UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have previously been on PDE5 inhibitors and have been respondents to the drug. Duration of treatment is 4 weeks.

Condition Intervention Phase
Impotence Drug: UK0369,003 Drug: Cialis (Tadalafil) Phase 2

Study Type: Interventional
Study Design: 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 Duration Of Action, Safety And Toleration Of Differing Doses and Combinations Of Immediate and Modified Release Formulations Of UK-369,003 and Cialis Compared To Placebo In Adult Male Subjects With Erectile Dysfunction

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of duration of action, safety & toleration of the investigational drug and Cialis

Secondary Outcome Measures:
  • Assess safety & toleration over 4 week treatment period

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Erectile Dysfunction

Exclusion Criteria:

  • Alpha blockers and Nitrates of any preparation
  Contacts and Locations
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Please refer to this study by its identifier: NCT00174486

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00174486     History of Changes
Other Study ID Numbers: A3711030
Study First Received: September 12, 2005
Last Updated: July 23, 2006

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 21, 2017