Use of Rosiglitazone in the Treatment of Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Endometriosis

Keywords

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Peroxisome Proliferator-Activated Receptors treatment of endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Dan Lebovic

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan I Lebovic, MD, MA

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 15474065 (View on PubMed)

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.

Reference Type DERIVED

PMID: 19641325 (View on PubMed)

Other Identifiers

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1K23HD043952-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2004-1013

Identifier Type: -

Identifier Source: org_study_id