Ejaculation Clinical Trial
Official title:
A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral UK-390,957 in Men With Premature Ejaculation
Verified date | November 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.
Status | Completed |
Enrollment | 460 |
Est. completion date | June 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Premature ejaculation as defined by DSM-IV Exclusion Criteria: - History of erectile dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Albany | New York |
United States | Pfizer Investigational Site | Anaheim | California |
United States | Pfizer Investigational Site | Atherton | California |
United States | Pfizer Investigational Site | Aurora | Colorado |
United States | Pfizer Investigational Site | Aventura | Florida |
United States | Pfizer Investigational Site | Beachwood | Ohio |
United States | Pfizer Investigational Site | Beverly Hills | California |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Durham | North Carolina |
United States | Pfizer Investigational Site | Edison | New Jersey |
United States | Pfizer Investigational Site | Endwell | New York |
United States | Pfizer Investigational Site | Evansville | Indiana |
United States | Pfizer Investigational Site | Fort Wayne | Indiana |
United States | Pfizer Investigational Site | Fort Worth | Texas |
United States | Pfizer Investigational Site | Germantown | Tennessee |
United States | Pfizer Investigational Site | Houston | Texas |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Kansas City | Missouri |
United States | Pfizer Investigational Site | Knoxville | Tennessee |
United States | Pfizer Investigational Site | Laguna Woods | California |
United States | Pfizer Investigational Site | Lexington | Kentucky |
United States | Pfizer Investigational Site | Madisonville | Kentucky |
United States | Pfizer Investigational Site | Memphis | Tennessee |
United States | Pfizer Investigational Site | Metairie | Louisiana |
United States | Pfizer Investigational Site | Michigan City | Indiana |
United States | Pfizer Investigational Site | Milan | Tennessee |
United States | Pfizer Investigational Site | Milford | Massachusetts |
United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
United States | Pfizer Investigational Site | Minneapolis | Minnesota |
United States | Pfizer Investigational Site | New Brunswick | New Jersey |
United States | Pfizer Investigational Site | New Port Richey | Florida |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Newport Beach | California |
United States | Pfizer Investigational Site | Pembroke Pines | Florida |
United States | Pfizer Investigational Site | Plano | Texas |
United States | Pfizer Investigational Site | Redwood City | California |
United States | Pfizer Investigational Site | Reno | Nevada |
United States | Pfizer Investigational Site | San Antonio | Texas |
United States | Pfizer Investigational Site | San Diego | California |
United States | Pfizer Investigational Site | Southhaven | Mississippi |
United States | Pfizer Investigational Site | St. Clair Shores | Michigan |
United States | Pfizer Investigational Site | Tacoma | Washington |
United States | Pfizer Investigational Site | Tarzana | California |
United States | Pfizer Investigational Site | Tucson | Arizona |
United States | Pfizer Investigational Site | Tulsa | Oklahoma |
United States | Pfizer Investigational Site | Voorhees | New Jersey |
United States | Pfizer Investigational Site | Walnut Creek | California |
United States | Pfizer Investigational Site | Waterbury | Connecticut |
United States | Pfizer Investigational Site | West Seneca | New York |
United States | Pfizer Investigational Site | Williamsville | New York |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of efficacy and safety | |||
Secondary | Assessment of Quality of Sexual Life |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01021670 -
An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride
|
Phase 4 | |
Completed |
NCT00210613 -
A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation
|
Phase 3 | |
Completed |
NCT00211107 -
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation.
|
Phase 3 | |
Completed |
NCT00219609 -
Assessment Of Safety Of UK-390,957
|
Phase 2/Phase 3 | |
Completed |
NCT00219635 -
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
|
Phase 2/Phase 3 | |
Terminated |
NCT02918227 -
Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
|
N/A | |
Completed |
NCT00219583 -
Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation
|
Phase 2/Phase 3 | |
Completed |
NCT01366664 -
A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin
|
Phase 1 | |
Completed |
NCT01230762 -
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
|
Phase 3 | |
Completed |
NCT00211094 -
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
|
Phase 3 |