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Trial record 1 of 1 for:    NCT00141349
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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.
 
ClinicalTrials.gov Identifier: NCT00141349
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : July 25, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date July 25, 2006
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
The time needed to obtain an erection hard enough to attempt sexual intercourse.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2005)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • 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 (IIEF): qu
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: UK-369,003
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141349
Other Study ID Numbers  ICMJE A3711029
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP