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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Pfizer Identifier: NCT00219609     History of Changes
Other Study ID Numbers: A3871028
Study First Received: September 9, 2005
Last Updated: November 5, 2012 processed this record on September 21, 2017