This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Treatment of Endometriosis Pain with Rosiglitazone: An Open Label, Phase 2a Clinical Trial The purpose of this open labeled, phase 2a clinical trial is to determine if a newer medicine, rosiglitazone, is effective in treating pain associated with endometriosis. Current treatments for endometriosis are limited for two reasons. One is because the disease tends to come back after the treatment is stopped. The other reason is that some of the medications have side effects that cannot be tolerated by patients for long periods of time. By doing this study we hope to determine if rosiglitazone can be used to effectively reduce pain in endometriosis. If this study shows that rosiglitazone is as an effective treatment or better drug than oral contraceptives for endometriosis pain it might be possible to use rosiglitazone for long-term treatment. Women between the ages of 18 and 45 who seek pain relief due to surgically diagnosed stage I or II endometriosis at the University of Michigan Obstetrics and Gynecology Clinic are eligible for this study. Patients who are using abstinence, condoms, diaphragm, or have been surgically sterilized and willing to continue this mode of birth control will be included in this study. Approximately 25 women with a history of stage I or II endometriosis will be recruited. Participants will be assigned rosiglitazone 4 mg (continuously) taken once-a-day for a period of six months. All patients will be asked to complete three (5-minute) questionnaires from enrollment in the study. In addition, participants will complete a daily pain diary (10 seconds to assess) for 14 days at the beginning of the treatment and then at the end of treatment (6-months). They will be asked to give blood and urine samples during the early part of the menstrual cycle at the following time points: beginning, 2, 4, and 6 months into the study. The blood samples will be used to measure levels of progesterone, liver function, blood cell counts, blood glucose, creatinine, and electrolytes. The urine sample will be used to perform a pregnancy test.
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