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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00143117
Other study ID # A3871022
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 30, 2005
Last updated November 5, 2012
Start date August 2004
Est. completion date June 2005

Study information

Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
UK-390,957


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of efficacy and safety
Secondary Assessment of Quality of Sexual Life
See also
  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 NCT00219635 - Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT00219609 - Assessment Of Safety Of UK-390,957 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