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Assessment Of Safety Of UK-390,957

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ClinicalTrials.gov Identifier: NCT00219609
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Ejaculation Drug: UK-390,957 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1058 participants
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
Study Start Date : January 2005
Primary Completion Date : March 2006
Study Completion Date : March 2006

Primary Outcome Measures :
  1. Assessment of safety

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219609

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00219609     History of Changes
Other Study ID Numbers: A3871028
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012