Endometriosis: Immunomodulation

NCT01184144 | Withdrawn Phase 2

• 1 other identifier: H-2010-0066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endometriosis

Keywords

Endometriosis; Peritoneal fluid; Cytokines; Peroxisome Proliferator-Activated Receptors

Outcome Measures

Primary Outcomes (1)

• Peritoneal cytokine levels

  Within 1 year

Study Arms (2)

pioglitazone

EXPERIMENTAL

Pioglitazone study drug

Drug: Pioglitazone

No drug

NO INTERVENTION

"Placebo" like comparitor

Interventions

Pioglitazone DRUG

Pioglitazone, 30 mg, by mouth daily for 2 weeks

Also known as: Actos

pioglitazone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.
• Diabetes mellitus.
• Known pregnancy or positive pregnancy test.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dan I Lebovic, MD

  Univ Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 2, 2015

Record last verified: 2012-04