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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174486
First received: September 12, 2005
Last updated: July 23, 2006
Last verified: November 2005
  Purpose

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
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 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
  Eligibility

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

Inclusion Criteria:

  • Erectile Dysfunction

Exclusion Criteria:

  • Alpha blockers and Nitrates of any preparation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174486

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

No publications provided

ClinicalTrials.gov Identifier: NCT00174486     History of Changes
Other Study ID Numbers: A3711030
Study First Received: September 12, 2005
Last Updated: July 23, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 23, 2014