Criteria
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
