Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ERB-041
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
Secondary Outcome Measures
Clinical and subject assessment of symptoms related to endometriosis and the
use of analgesia to relieve symptoms.
Full Information
NCT ID
NCT00110487
First Posted
May 9, 2005
Last Updated
April 30, 2015
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00110487
Brief Title
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ERB-041
Primary Outcome Measure Information:
Title
To assess the effects and to compare the safety profile of an investigational
Title
medication on the relief of endometriosis-related symptoms.
Secondary Outcome Measure Information:
Title
Clinical and subject assessment of symptoms related to endometriosis and the
Title
use of analgesia to relieve symptoms.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Boynton
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33758
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Lanham
State/Province
Maryland
ZIP/Postal Code
20706
Country
United States
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9032
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6188
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
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