Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With 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: NCT00174486
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 25, 2006
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Brief Summary:
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 or disease Intervention/treatment Phase
Impotence Drug: UK0369,003 Drug: Cialis (Tadalafil) 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 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
Study Start Date : February 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

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

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

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

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): NCT00174486

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer Identifier: NCT00174486     History of Changes
Other Study ID Numbers: A3711030
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 25, 2006
Last Verified: November 2005

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