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

NCT ID: NCT00110487

Last Updated: 2015-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ERB-041

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Carmichael, California, United States

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La Jolla, California, United States

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Redding, California, United States

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San Diego, California, United States

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Lakewood, Colorado, United States

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Aventura, Florida, United States

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Boynton Beach, Florida, United States

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Celebration, Florida, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Palm Harbor, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Arlington Heights, Illinois, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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South Bend, Indiana, United States

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Shreveport, Louisiana, United States

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Lanham, Maryland, United States

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Laurel, Maryland, United States

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Detroit, Michigan, United States

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Chaska, Minnesota, United States

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Chesterfield, Missouri, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Charlotte, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Eugene, Oregon, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Webster, Texas, United States

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Sandy City, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Countries

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United States

Other Identifiers

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3142A2-200

Identifier Type: -

Identifier Source: org_study_id

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