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

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00110487
Collaborator
(none)
200
Enrollment
46
Locations
23
Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2005
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. To assess the effects and to compare the safety profile of an investigational []

  2. medication on the relief of endometriosis-related symptoms. []

Secondary Outcome Measures

  1. Clinical and subject assessment of symptoms related to endometriosis and the []

  2. use of analgesia to relieve symptoms. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Arizona United States 85015
2 Tucson Arizona United States 85710
3 Carmichael California United States 95608
4 La Jolla California United States 92093
5 Redding California United States 96001
6 San Diego California United States 92123
7 Lakewood Colorado United States 80228
8 Aventura Florida United States 33180
9 Boynton Florida United States 33437
10 Celebration Florida United States 34747
11 Clearwater Florida United States 33758
12 Miami Florida United States 33136
13 Miami Florida United States 33143
14 New Port Richey Florida United States 34652
15 Ocala Florida United States 34471
16 Palm Harbor Florida United States 34684
17 Alpharetta Georgia United States 30005
18 Atlanta Georgia United States 30342
19 Arlington Heights Illinois United States 60005
20 Champaign Illinois United States 61820
21 Chicago Illinois United States 60611
22 Chicago Illinois United States 60637
23 Oak Brook Illinois United States 60523
24 South Bend Indiana United States 46601
25 Shreveport Louisiana United States 71103
26 Lanham Maryland United States 20706
27 Laurel Maryland United States 20707
28 Detroit Michigan United States 48201
29 Chaska Minnesota United States 55318
30 Chesterfield Missouri United States 63017
31 Las Vegas Nevada United States 89104
32 Berlin New Jersey United States 08009
33 Charlotte North Carolina United States 28209
34 Fargo North Dakota United States 58104
35 Cincinnati Ohio United States 45267
36 Cleveland Ohio United States 44195
37 Eugene Oregon United States 97401
38 Greenville South Carolina United States 29605
39 Greer South Carolina United States 29651
40 Dallas Texas United States 75390-9032
41 Fort Worth Texas United States 76104
42 Webster Texas United States 77598
43 Sandy Utah United States 84070
44 Norfolk Virginia United States 23507-1627
45 Richmond Virginia United States 23298
46 Madison Wisconsin United States 53792-6188

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00110487
Other Study ID Numbers:
  • 3142A2-200
First Posted:
May 10, 2005
Last Update Posted:
May 1, 2015
Last Verified:
Dec 1, 2007
Keywords provided by , ,
Endometriosis
Additional relevant MeSH terms:
Endometriosis

Study Results

No Results Posted as of May 1, 2015