Trial of Mifepristone for Fibroids

University of Rochester

Status and phase

Completed

Phase 3

Conditions

Leiomyoma

Treatments

Drug: Mifepristone

Drug: Inert Capsule

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00133705

RO1-HD042578-2

Details and patient eligibility

About

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

Full description

This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.

Enrollment

70 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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