Endometriosis: Immunomodulation
Effect of Pioglitazone on Peritoneal Cytokines in Women With Endometriosis
Study Overview
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.
Study Type
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy woman age 18 - 45 years.
- Regular cycles (24-35 days).
- Pelvic pain ≥ 3 months.
- Negative pregnancy test.
- Non-lactating.
- No prior (<3 months) use of hormonal therapy.
- No history of liver disease.
- Suspected endometriosis and scheduled for surgery to confirm this diagnosis
- Surgery scheduled in follicular phase.
- Consent to participate in the study.
Enrollment into data analysis portion of study if:
- Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation.
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.
- Diabetes mellitus.
- Known pregnancy or positive pregnancy test.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pioglitazone
Pioglitazone study drug
|
Pioglitazone, 30 mg, by mouth daily for 2 weeks
Other Names:
|
|
No Intervention: No drug
"Placebo" like comparitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peritoneal cytokine levels
Time Frame: Within 1 year
|
Within 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dan I Lebovic, MD, Univ Wisconsin
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2010-0066
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