Trial of Mifepristone for Fibroids

Inclusion Criteria:

• Gender: Female
• Age: 18 - premenopausal
• Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
• Have a total uterine volume greater than or equal to 160 cc by ultrasound measurementand at least one fibroid that is => 2.5cm in size
• Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Qualityof Life scale
• Declined standard treatment options for symptomatic fibroids
• Agree to use a double-barrier method (condoms, diaphragms) or other effectivenon-hormonal methods of contraception (abstinence, sterilization) throughoutparticipation in the study to prevent pregnancy and to report any exposure topregnancy to the research staff immediately
• Willing and able to give informed consent
• Willing and able to comply with study requirements

Exclusion Criteria:

• Current or planned pregnancy during the study period
• Menopausal, as indicated by follicle stimulating hormone (FSH) level of the referencelaboratory
• Currently breast-feeding
• Untreated abnormal pap smear
• Presence of conditions other than fibroids contributing to pain and/or bleeding
• Hemoglobin < 9.0 mg/dl
• Presence of adnexal masses or tenderness indicating further evaluation or surgery
• Grade III or IV hydronephrosis by ultrasound
• Severe, active mental health disorder
• Active substance abuse or dependence
• Presence of any contraindication to mifepristone including:
• Adrenal insufficiency by history
• Sickle cell disease
• Active liver disease (liver function tests greater than 1.5 times upper range ofnormal)
• Severe, respiratory disease (P02 saturation< 92%)
• Renal disease (serum creatinine > 1.5 mg/dl)
• Blood clotting defect. (abnormal PT and PTT)
• Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)
• Current or recent (within the past 3 months) use of the following medications:
• Oral or systemic corticosteroids
• Hormones: estrogens, progestins, oral contraceptives
• Danazol, anticoagulants
• Herbal or botanical supplements with possible hormonal effects.
• Use within the past six months of the gonadotropin releasing hormones (GnRH) analogsor Depo-Provera.
• Current or planned use during the study of any of the following medications/orproducts:
• ketoconazole,
• itraconazole,
• erythromycin,
• grapefruit juice,
• rifampin,
• St John's Wort,
• phenytoin,
• phenobarbital, or
• carbamazepine