NCT00115661

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

June 23, 2005

Last Update Submit

October 16, 2012

Conditions

Endometriosis

Keywords

Peroxisome Proliferator-Activated Receptorstreatment of endometriosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • 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.

    PMID: 15474065BACKGROUND

  • 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.

    PMID: 19641325DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dan I Lebovic, MD, MA

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations

US(1)