Endometriosis: Immunomodulation

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Endometriosis

Clinical Trial Details

NCT number	NCT01184144
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	August 2010
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01931670` - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Recruiting	`NCT05648669` - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Completed	`NCT04665414` - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed	`NCT03690765` - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting	`NCT05153512` - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Completed	`NCT04565470` - Strategies of Self-management of Endometriosis Symptoms
Completed	`NCT03613298` - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.	N/A
Withdrawn	`NCT05568940` - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting	`NCT03464799` - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting	`NCT03002870` - Characteristics of Patient Population With Endometriosis	N/A
Completed	`NCT02973854` - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn	`NCT03272360` - Endometriosis Biomarker Discovery Study	N/A
Recruiting	`NCT02481739` - Laparoscopic Surgical Management of Endometriosis on Fertility	N/A
Active, not recruiting	`NCT02754648` - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve	N/A
Completed	`NCT06106932` - GnRH-a on Angiogenesis of Endometriosis	N/A
Completed	`NCT02387931` - Supplementation in Adolescent Girls With Endometriosis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.