NCT00115661

Use of Rosiglitazone in the Treatment of Endometriosis

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Rosiglitazone

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-06-24
• Last updated: 2012-10-17

Locations

1 site across 1 country: United States