Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

NCT00110487

Last updated date
Study Location
Phoenix, Arizona, 85015, 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.
Endometriosis
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 5 years

- Not pregnant and not lactating

- Willing to use non-hormonal contraception, history of regular menstrual cycles

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


- Hysterectomy, surgical treatment for endometriosis within 3 months


- Certain medications for the treatment of endometriosis


- Previous history of a malignancy


- Abnormalities on physical or gyn exams and abnormal lab tests

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EndometriosisStudy Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
NCT00110487
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Carmichael, California
  4. La Jolla, California
  5. Redding, California
  6. San Diego, California
  7. Lakewood, Colorado
  8. Aventura, Florida
  9. Boynton, Florida
  10. Celebration, Florida
  11. Clearwater, Florida
  12. Miami, Florida
  13. Miami, Florida
  14. New Port Richey, Florida
  15. Ocala, Florida
  16. Palm Harbor, Florida
  17. Alpharetta, Georgia
  18. Atlanta, Georgia
  19. Arlington Heights, Illinois
  20. Champaign, Illinois
  21. Chicago, Illinois
  22. Chicago, Illinois
  23. Oak Brook, Illinois
  24. South Bend, Indiana
  25. Shreveport, Louisiana
  26. Lanham, Maryland
  27. Laurel, Maryland
  28. Detroit, Michigan
  29. Chaska, Minnesota
  30. Chesterfield, Missouri
  31. Las Vegas, Nevada
  32. Berlin, New Jersey
  33. Charlotte, North Carolina
  34. Fargo, North Dakota
  35. Cincinnati, Ohio
  36. Cleveland, Ohio
  37. Eugene, Oregon
  38. Greenville, South Carolina
  39. Greer, South Carolina
  40. Dallas, Texas
  41. Fort Worth, Texas
  42. Webster, Texas
  43. Sandy, Utah
  44. Norfolk, Virginia
  45. Richmond, Virginia
  46. Madison, Wisconsin
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women
Brief Summary The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
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: September 29, 2005)
200
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Surgical diagnosis of endometriosis within 5 years
  • Not pregnant and not lactating
  • Willing to use non-hormonal contraception, history of regular menstrual cycles

Exclusion Criteria:

  • Hysterectomy, surgical treatment for endometriosis within 3 months
  • Certain medications for the treatment of endometriosis
  • Previous history of a malignancy
  • Abnormalities on physical or gyn exams and abnormal lab tests
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00110487
Other Study ID Numbers  ICMJE 3142A2-200
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
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