Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
NCT00110487
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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EndometriosisStudy Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
NCT00110487
- Phoenix, Arizona
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- La Jolla, California
- Redding, California
- San Diego, California
- Lakewood, Colorado
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- Boynton, Florida
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- South Bend, Indiana
- Shreveport, Louisiana
- Lanham, Maryland
- Laurel, Maryland
- Detroit, Michigan
- Chaska, Minnesota
- Chesterfield, Missouri
- Las Vegas, Nevada
- Berlin, New Jersey
- Charlotte, North Carolina
- Fargo, North Dakota
- Cincinnati, Ohio
- Cleveland, Ohio
- Eugene, Oregon
- Greenville, South Carolina
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- Richmond, Virginia
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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 | 200 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | December 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||