Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
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
1 other identifier
interventional
200
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2005
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 9, 2005
CompletedFirst Posted
Study publicly available on registry
May 10, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 1, 2015
December 1, 2007
May 9, 2005
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
Secondary Outcomes (2)
Clinical and subject assessment of symptoms related to endometriosis and the
use of analgesia to relieve symptoms.
Interventions
Eligibility Criteria
You may qualify if:
- Surgical diagnosis of endometriosis within 5 years
- Not pregnant and not lactating
- Willing to use non-hormonal contraception, history of regular menstrual cycles
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Unknown Facility
Phoenix, Arizona, 85015, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
La Jolla, California, 92093, United States
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Redding, California, 96001, United States
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San Diego, California, 92123, United States
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Lakewood, Colorado, 80228, United States
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Aventura, Florida, 33180, United States
Unknown Facility
Boynton Beach, Florida, 33437, United States
Unknown Facility
Celebration, Florida, 34747, United States
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Clearwater, Florida, 33758, United States
Unknown Facility
Miami, Florida, 33136, United States
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Miami, Florida, 33143, United States
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New Port Richey, Florida, 34652, United States
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Ocala, Florida, 34471, United States
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Palm Harbor, Florida, 34684, United States
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Alpharetta, Georgia, 30005, United States
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Atlanta, Georgia, 30342, United States
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Arlington Heights, Illinois, 60005, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60637, United States
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Oak Brook, Illinois, 60523, United States
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South Bend, Indiana, 46601, United States
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Shreveport, Louisiana, 71103, United States
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Lanham, Maryland, 20706, United States
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Laurel, Maryland, 20707, United States
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Detroit, Michigan, 48201, United States
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Chaska, Minnesota, 55318, United States
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Chesterfield, Missouri, 63017, United States
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Las Vegas, Nevada, 89104, United States
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Berlin, New Jersey, 08009, United States
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Charlotte, North Carolina, 28209, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44195, United States
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Eugene, Oregon, 97401, United States
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Greenville, South Carolina, 29605, United States
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Greer, South Carolina, 29651, United States
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Dallas, Texas, 75390-9032, United States
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Fort Worth, Texas, 76104, United States
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Webster, Texas, 77598, United States
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Sandy City, Utah, 84070, United States
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Norfolk, Virginia, 23507-1627, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Madison, Wisconsin, 53792-6188, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2005
First Posted
May 10, 2005
Study Start
January 1, 2005
Study Completion
December 1, 2006
Last Updated
May 1, 2015
Record last verified: 2007-12