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

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ClinicalTrials.gov Identifier: NCT00219583
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Assessment of efficacy and safety UK-390,957.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessment of efficacy and safety

Secondary Outcome Measures :
  1. Assessment of quality of sexual life

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00219583


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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00219583     History of Changes
Other Study ID Numbers: A3871027
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Premature Ejaculation
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders