Status:
TERMINATED
Use of Rosiglitazone in the Treatment of Endometriosis
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Berlex Foundation
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.
Detailed Description
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometr...
Eligibility Criteria
Inclusion
- Healthy women ages 18 - 45 years.
- Regular menstrual cycles (24-35 days).
- Pelvic pain ≥ 3 months with cyclical component.
- Negative pregnancy test and must use nonhormonal contraception.
- Non-lactating.
- No history of liver disease.
- Consent to participate in the study.
- Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation within the past 4 years.
Exclusion
- Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures.
- Active or prior infection with hepatitis, human immunodeficiency virus (HIV) infection, or history of high-risk activities (e.g., IV drug abuse) which would increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected.
- Patients with liver dysfunction (elevated liver enzymes \> 2 times the upper limit of normal).
- Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- Elevated WBC.
- NYHA functional class I-IV heart failure.
- Diabetics.
- Known pregnancy or positive pregnancy test.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00115661
Start Date
July 1 2005
End Date
May 1 2006
Last Update
October 17 2012
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109