Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

INCLUSION CRITERIA

• Female gender-to evaluate effects in the target population for clinical trials.
• History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin:
• 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.
• Uterine leiomyoma(ta) of at least 2 cm size.
• In 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. Interval use of over-the-counter drugs is acceptable but must be recorded.
• Menstrual cycles of 24 - 35 days.
• Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts.
• Willing and able to comply with study requirements.
• Age 25 to 50.
• Using mechanical (condoms, diaphragms) sterilization or abstinence methods of contraception for the duration of the study.
• Negative urine pregnancy test.
• Body mass index (BMI) less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate.
• Creatinine less than 1.3 mg/dL.
• Liver function tests within 130% of upper limit.
• If interested in hysterectomy, no desire for fertility.

EXCLUSION CRITERIA

• Significant abnormalities in the history, physical or laboratory examination.
• Pregnancy.
• Lactation.
• Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year.
• Unexplained vaginal bleeding.
• History of malignancy within the past 5 years.
• Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.
• Use of agents known to induce hepatic P450 enzymes; use of imidazoles.
• Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity.
• Follicle stimulating hormone (FSH) greater than 20 IU/mL.
• Untreated cervical dysplasia.
• Need for interval use of narcotics.
• Abnormal adnexal/ovarian mass.
• Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months.
• Contradiction to anesthesia, for women planning surgery.
• Genetic causes of leiomyomata.
• Previous participation in the study.
• Known recent rapid growth of fibroids, defined as a doubling in size in six months.