Clinical trial NCT00141349: Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The time needed to obtain an erection hard enough to attempt sexual intercourse.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: