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.
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
- 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.
- 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.
- 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
- 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.
- Known pregnancy or positive pregnancy test.