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NIH Fibroid Treatment Study NIH Fibroid Treatment Study NIH Fibroid Treatment Study
NIH Fibroid Treatment Study NIH Fibroid Treatment Study NIH Fibroid Treatment Study
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Inclusion Criteria

  • Good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Use of over-the counter drugs is acceptable but must be recorded.
  • Menstrual cycles of 24 – 35 days
  • Hemoglobin > 10 g/dL
  • Willing and able to comply with study requirements
  • Age 33 to 50
  • Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study
  • Negative urine pregnancy test
  • BMI (body mass index) < 30. This is calculated by dividing the weight in kilograms by the height in meters, squared
  • Able to read and speak English fluently to allow accurate self-administration of medication, recording of symptoms and unassisted completion of questionnaire
  • Normal kidney and liver function
  • History of uterine leiomyoma at least 2 cm in size causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994)
  • Excessive uterine bleeding will be evidenced by either of the following—profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss OR
  • Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection
  • No desire for fertility; willing to undergo hysterectomy

Exclusion Criteria

  • Significant abnormalities in the history, physical or laboratory examination
  • Pregnancy or breast feeding
  • Use of oral, injectable or inhaled glucocorticoids (steroids) or megesterol within the last year
  • Unexplained vaginal bleeding
  • History of malignancy within the past 5 years
  • Use of any estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry
  • Use of certain drugs that affect liver function
  • Current use of GnRH analogs or other compounds that affect menstrual cyclicity
  • FSH > 20 IU/mL