Know Cancer

forgot password

Randomized Control Trial Of Mifepristone for Fibroids

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

Randomized Control Trial Of Mifepristone for Fibroids

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.

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

- 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

- 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

- ketoconazole,

- itraconazole,

- erythromycin,

- grapefruit juice,

- rifampin,

- St John's Wort,

- phenytoin,

- phenobarbital, or

- carbamazepine

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Uterine Volume

Outcome Description:

Uterine volume is measured in mLs

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Kevin Fiscella, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester School of Medicine & Dentistry


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

June 2010

Related Keywords:

  • Leiomyoma
  • A benign tumor derived from smooth uterine muscle tissue.
  • Leiomyoma
  • Myofibroma



University of Rochester School of Medicine & Dentistry Rochester, New York  14642