Randomized Control 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
measurement and 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
Quality of Life scale

- Declined standard treatment options for symptomatic fibroids

- Agree to use a double-barrier method (condoms, diaphragms) or other effective
non-hormonal methods of contraception (abstinence, sterilization) throughout
participation in the study to prevent pregnancy and to report any exposure to
pregnancy 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 reference
laboratory

- 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 of
normal)

- 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) analogs
or Depo-Provera.

- Current or planned use during the study of any of the following medications/or
products:

- ketoconazole,

- itraconazole,

- erythromycin,

- grapefruit juice,

- rifampin,

- St John's Wort,

- phenytoin,

- phenobarbital, or

- carbamazepine