Clinical trial: Use of Rosiglitazone in the Treatment of Endometriosis (NCT00115661)

Eligibility criteria:
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.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction