Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

NCT00318500

Last updated date
Study Location
Montgomery, Alabama, 36116, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Surgical diagnosis of endometriosis within the last 10 years

- Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

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


- Conditions requiring the use of chronic pain therapy


- Prophylactic use of analgesics to avoid endometriosis-related pain

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Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic PainStudy Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
NCT00318500
  1. Montgomery, Alabama
  2. Chandler, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Tucson, Arizona
  6. San Francisco, California
  7. Vista, California
  8. Denver, Colorado
  9. Denver, Colorado
  10. New Britain, Connecticut
  11. Clearwater, Florida
  12. New Port Richey, Florida
  13. Plantation, Florida
  14. Venice, Florida
  15. West Palm Beach, Florida
  16. West Palm Beach, Florida
  17. Marietta, Georgia
  18. Idaho Falls, Idaho
  19. Oak Brook, Illinois
  20. Evansville, Indiana
  21. Reno, Nevada
  22. Lawrenceville, New Jersey
  23. Durham, North Carolina
  24. New Bern, North Carolina
  25. Raleigh, North Carolina
  26. Winston-Salem, North Carolina
  27. Cleveland, Ohio
  28. Miamisburg, Ohio
  29. Oklahoma City, Oklahoma
  30. Portland, Oregon
  31. Abington, Pennsylvania
  32. Lansdale, Pennsylvania
  33. Philadelphia, Pennsylvania
  34. Philadelphia, Pennsylvania
  35. Pittsburgh, Pennsylvania
  36. Columbia, South Carolina
  37. Greenville, South Carolina
  38. Bristol, Tennessee
  39. Chattanooga, Tennessee
  40. Memphis, Tennessee
  41. Corpus Christi, Texas
  42. San Antonio, Texas
  43. West Valley City, Utah
  44. Norfolk, Virginia
  45. Richmond, Virginia
  46. Richmond, Virginia
  47. Virginia Beach, Virginia
  48. Renton, Washington
  49. Madison, Wisconsin
  50. Randwick, New South Wales
  51. Sydney, New South Wales
  52. Richmond, Victoria
  53. Nedlands, Western Australia
  54. Herestraat, Leuven
  55. Calgary, Alberta
  56. Vancouver, British Columbia
  57. Winnipeg, Manitoba
  58. Halifax, Nova Scotia
  59. London, Ontario
  60. Toronto, Ontario
  61. Saskatoon, Saskatchewan
  62. Hong Kong,
  63. Cape Town, Capetown
  64. Port Elizabeth, Eastern Cape
  65. Roodepoort, Jgb Gauteng
  66. Durban, KwaZulu Natal
  67. Nottingham, Nottinghamshire
  68. Glasgow, Scotland
  69. Sheffield, South Yorshire
  70. Swindon, Wiltshire
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women
Brief Summary The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Dysmenorrhea
  • Dyspareunia
  • Endometriosis
  • Pelvic Pain
Intervention  ICMJE Drug: ERB-041
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: April 25, 2006)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Surgical diagnosis of endometriosis within the last 10 years
  • Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion Criteria:

  • Conditions requiring the use of chronic pain therapy
  • Prophylactic use of analgesics to avoid endometriosis-related pain
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Hong Kong,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318500
Other Study ID Numbers  ICMJE 3142A2-203
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor United Kingdom, [email protected]
Principal Investigator:Trial ManagerFor Australia and Hong Kong, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Canada, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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