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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 9, 2005
Last updated: November 5, 2012
Last verified: November 2012

Assessment of efficacy and safety UK-390,957.

Condition Intervention Phase
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-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 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)

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

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 identifier: NCT00219583

  Show 50 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00219583     History of Changes
Other Study ID Numbers: A3871027
Study First Received: September 9, 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 processed this record on April 20, 2014