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NCT00219635 Clinical Trial

Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation

Ejaculation Clinical Trial

Official title:
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219635
Other study ID # A3871029
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 9, 2005
Last updated November 5, 2012
Start date January 2005
Est. completion date July 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

Assessment of efficacy and safety UK-390,957

Recruitment information / eligibility
Status Completed
Enrollment 138
Est. completion date July 2005
Est. primary completion date July 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
Australia Pfizer Investigational Site Malvern Victoria
Australia Pfizer Investigational Site St Leonards New South Wales
Canada Pfizer Investigational Site Barrie Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Victoria British Columbia
United Kingdom Pfizer Investigational Site Devon
United Kingdom Pfizer Investigational Site Nr Lichfield Staffordshire
United States Pfizer Investigational Site Beachwood Ohio
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site San Bernardino California
United States Pfizer Investigational Site Washington Missouri
United States Pfizer Investigational Site Watertown Massachusetts
United States Pfizer Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

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 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 NCT00143117 - Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation Phase 2/Phase 3
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 NCT00211094 - A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation Phase 3
Completed NCT01230762 - An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation Phase 3

External Links