Assessment Of Safety Of UK-390,957

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

To determine whether UK-390,957 is a safe treatment for premature ejaculation.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of safety

Estimated Enrollment: 1058
Study Start Date: January 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (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:

  • Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV

Exclusion Criteria:

  • No drug related serious adverse events
  Contacts and Locations
Please refer to this study by its identifier: NCT00219609

  Show 83 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00219609     History of Changes
Other Study ID Numbers: A3871028
Study First Received: September 9, 2005
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration processed this record on April 17, 2014