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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141349

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 II

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study ID Numbers:	A3711029
Study First Received:	August 30, 2005
Last Updated:	July 23, 2006
ClinicalTrials.gov Identifier:	NCT00141349
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 13, 2009