Trial of Mifepristone for Fibroids

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Mifepristone

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