Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

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NCT00143117

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Study Location
Pfizer Investigational Site
Tucson, Arizona, , United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ejaculation
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Premature ejaculation as defined by DSM-IV

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of erectile dysfunction

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EjaculationAssessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
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  2. Anaheim, California
  3. Atherton, California
  4. Beverly Hills, California
  5. Laguna Woods, California
  6. Newport Beach, California
  7. Redwood City, California
  8. San Diego, California
  9. Tarzana, California
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  11. Aurora, Colorado
  12. Waterbury, Connecticut
  13. Aventura, Florida
  14. New Port Richey, Florida
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  16. Evansville, Indiana
  17. Fort Wayne, Indiana
  18. Indianapolis, Indiana
  19. Michigan City, Indiana
  20. Lexington, Kentucky
  21. Madisonville, Kentucky
  22. Metairie, Louisiana
  23. Milford, Massachusetts
  24. St. Clair Shores, Michigan
  25. Minneapolis, Minnesota
  26. Southhaven, Mississippi
  27. Kansas City, Missouri
  28. Reno, Nevada
  29. Edison, New Jersey
  30. New Brunswick, New Jersey
  31. Voorhees, New Jersey
  32. Albany, New York
  33. Endwell, New York
  34. New York, New York
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  38. Durham, North Carolina
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  43. Memphis, Tennessee
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  19. Madisonville, Kentucky
  20. Metairie, Louisiana
  21. Watertown, Massachusetts
  22. Saint Clair Shores, Michigan
  23. Minneapolis, Minnesota
  24. Southhaven, Mississippi
  25. Kansas City, Missouri
  26. Edison, New Jersey
  27. New Brunswick, New Jersey
  28. Vorhees, New Jersey
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  31. New York, New York
  32. West Seneca, New York
  33. Williamsville, New York
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  39. Knoxville, Tennessee
  40. Memphis, Tennessee
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  42. Dallas, Texas
  43. Houston, Texas
  44. San Antonio, Texas
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  46. Milwuakee, Wisconsin
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  48. Spring Hill, Queensland
  49. Adelaide, South Australia
  50. Malvern, Victoria
  51. Nedlands, Western Australia
  52. Mistelbach,
  53. Salzburg,
  54. Barrie, Ontario
  55. London, Ontario
  56. Oakville, Ontario
  57. Toronto, Ontario
  58. Montreal, Quebec
  59. Montréal, Quebec
  60. Brno,
  61. Prague 5,
  62. Praha 2,
  63. Lyon Cedex 03,
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  65. Hannover,
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  71. Milan,
  72. Roma,
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  77. Skovde,
  78. Stockholm,
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  81. Balcova, Izmir
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Advanced Information
Descriptive Information
Brief Title  ICMJE Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
Official Title  ICMJE A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral UK-390,957 in Men With Premature Ejaculation
Brief Summary To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ejaculation
Intervention  ICMJE Drug: UK-390,957
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2005)		460
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premature ejaculation as defined by DSM-IV

Exclusion Criteria:

  • History of erectile dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143117
Other Study ID Numbers  ICMJE A3871022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP