Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00143117
First received: August 30, 2005
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Ejaculation
Drug: UK-390,957
Phase 2
Phase 3

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of efficacy and safety

Secondary Outcome Measures:
  • Assessment of Quality of Sexual Life

Estimated Enrollment: 460
Study Start Date: August 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

  • History of erectile dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143117

  Show 51 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00143117     History of Changes
Other Study ID Numbers: A3871022
Study First Received: August 30, 2005
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014