Trial of Mifepristone for Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma
Intervention: Mifepristone; Inert Capsule
Intervention description: Mifepristone 5mg/day by mouth for 6 months; sugar pill
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: A benign tumor derived from smooth uterine muscle tissue.

Summary:

      The purpose of this trial is to determine if low-dose mifepristone benefits women with
      symptomatic fibroids.
    

Eligibility criteria:

        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