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

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NCT00110487

Last updated on November 15, 2019
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Study Location
Phoenix, Arizona, 85015 United States
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Contact
1-800-718-1021
[email protected]
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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

NCT00110487
Pfizer
Completed
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

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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 SummaryThe 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 DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot 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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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