Use of Rosiglitazone in the Treatment of Endometriosis

Endometriosis Clinical Trial

Official title:

Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00115661
• Other study ID #: 2004-1013
• Secondary ID: 1K23HD043952-01A
• Status: Terminated
• Phase: Phase 2
• First received: June 23, 2005
• Last updated: October 16, 2012
• Start date: July 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.

Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

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.

• Diabetics.

• Known pregnancy or positive pregnancy test.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Berlex Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
Secondary	Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
Secondary	Physical component summary score of the SF-36 at baseline and at 3 and 6 months
Secondary	Cytokine quantification
Secondary	Proteomics
Secondary	Gene array analyses

External Links

•   University of Michigan Endometriosis Center