Endometriosis: Immunomodulation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dan Lebovic, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01184144
First received: August 13, 2010
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to compare the effect of pioglitazone versus no drug on soluble profinflammatory markers in peritoneal fluid of women with endometriosis.


Condition Intervention Phase
Endometriosis
Drug: Pioglitazone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Pioglitazone on Peritoneal Cytokines in Women With Endometriosis

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Peritoneal cytokine levels [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pioglitazone
Pioglitazone study drug
Drug: Pioglitazone
Pioglitazone, 30 mg, by mouth daily for 2 weeks
Other Name: Actos
No Intervention: No drug
"Placebo" like comparitor

Detailed Description:

The overall goal of this proposal is to assess modulation of immune mechanisms in endometriosis. Endometriosis is a common ailment affecting approximately five million reproductive-aged American women. We will test the efficacy of a novel immunomodulatory drug (peroxisome proliferator activated receptor gamma, PPAR-gamma, agonist), pioglitazone, to reduce peritoneal fluid cytokine concentrations in women with endometriosis compared with the non-treated controls (randomized controlled trial). Based on prior studies done by the investigator highlighting the major role of cytokines and the immune system in the genesis or propagation of endometriosis, these experiments could lead to improved translational treatment strategies and a better understanding of endometriosis. Acting through PPAR-gamma, TZDs inhibit proinflammatory cytokines as well as NF-kB, an important nuclear transcription factor for the production of many cytokines. Accordingly, since human endometrial epithelial and stromal cells contain PPAR-gamma, we felt i would be useful to evaluate the influence of a PPAR-gamma ligand, pioglitazone, on the concentration of specific peritoneal fluid cytokines.

Comparison: After the pre-trial screening, eligible subjects with presumed endometriosis and age 18-45 will be consented and randomly assigned to receive either pioglitazone (30 mg, daily)or no drug for 2 weeks. Peritoneal fluid will be collected at the time of surgery and the volume measured. All patients enrolled in the study will have their surgery during the follicular phase of the cycle in order to minimize differences in volume and cytokine concentration due to the cyclical changes. The primary measure will be the peritoneal fluid concentration comparisons of the two groups assessing six different cytokines.

  Eligibility

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

Inclusion Criteria:

  1. Healthy woman age 18 - 45 years.
  2. Regular cycles (24-35 days).
  3. Pelvic pain ≥ 3 months.
  4. Negative pregnancy test.
  5. Non-lactating.
  6. No prior (<3 months) use of hormonal therapy.
  7. No history of liver disease.
  8. Suspected endometriosis and scheduled for surgery to confirm this diagnosis
  9. Surgery scheduled in follicular phase.
  10. Consent to participate in the study.
  11. Enrollment into data analysis portion of study if:

    • Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation.

Exclusion Criteria:

  1. Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures.
  2. 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.
  3. Patients with liver dysfunction (elevated liver enzymes > 2 times the upper limit of normal).
  4. Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
  5. Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
  6. Elevated WBC.
  7. NYHA functional class I-IV heart failure.
  8. Diabetes mellitus.
  9. Known pregnancy or positive pregnancy test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184144

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Dan I Lebovic, MD Univ Wisconsin
  More Information

No publications provided

Responsible Party: Dan Lebovic, Associate Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01184144     History of Changes
Other Study ID Numbers: H-2010-0066
Study First Received: August 13, 2010
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Endometriosis
Peritoneal fluid
Cytokines
Peroxisome Proliferator-Activated Receptors

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014