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Trial record 1 of 1 for:    NCT00110487
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Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

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ClinicalTrials.gov Identifier: NCT00110487
Recruitment Status : Completed
First Posted : May 10, 2005
Last Update Posted : May 1, 2015
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE May 9, 2005
First Posted Date  ICMJE May 10, 2005
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
  • To assess the effects and to compare the safety profile of an investigational
  • medication on the relief of endometriosis-related symptoms.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00110487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
  • Clinical and subject assessment of symptoms related to endometriosis and the
  • use of analgesia to relieve symptoms.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Monitor Wyeth 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