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Use of Rosiglitazone in the Treatment of Endometriosis

Primary Purpose

Endometriosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Peroxisome Proliferator-Activated Receptors, treatment of endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • University of Michigan Health System

Outcomes

Primary Outcome Measures

28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months

Secondary Outcome Measures

Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
Physical component summary score of the SF-36 at baseline and at 3 and 6 months
Cytokine quantification
Proteomics
Gene array analyses

Full Information

First Posted
June 23, 2005
Last Updated
October 16, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Berlex Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00115661
Brief Title
Use of Rosiglitazone in the Treatment of Endometriosis
Official Title
Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to the meta-analysis about CV adverse effects of rosiglitazone.
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Berlex Foundation

4. Oversight

5. Study Description

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 endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial. Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Peroxisome Proliferator-Activated Receptors, treatment of endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Primary Outcome Measure Information:
Title
28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
Secondary Outcome Measure Information:
Title
Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
Title
Physical component summary score of the SF-36 at baseline and at 3 and 6 months
Title
Cytokine quantification
Title
Proteomics
Title
Gene array analyses

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: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan I Lebovic, MD, MA
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15474065
Citation
Lebovic DI, Kir M, Casey CL. Peroxisome proliferator-activated receptor-gamma induces regression of endometrial explants in a rat model of endometriosis. Fertil Steril. 2004 Oct;82 Suppl 3:1008-13. doi: 10.1016/j.fertnstert.2004.02.148.
Results Reference
background
PubMed Identifier
19641325
Citation
Moravek MB, Ward EA, Lebovic DI. Thiazolidinediones as therapy for endometriosis: a case series. Gynecol Obstet Invest. 2009;68(3):167-70. doi: 10.1159/000230713. Epub 2009 Jul 30.
Results Reference
derived

Learn more about this trial

Use of Rosiglitazone in the Treatment of Endometriosis

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