Protocol Number: 06-CH-0090
Women between 25 and 50 years of age who have regular menstrual cycles and a history of uterine fibroids that cause heavy bleeding, pressure, or pain may be eligible for this study. Candidates are screened with a medical history and physical examination, including breast and pelvic examination, blood and urine tests, a quality-of-life questionnaire, and a home urine test for LH (leuteinizing hormone) surge. They are given a diary to record the LH surge, days of vaginal spotting or bleeding, and symptoms. Participation includes the following: (Baseline Studies (First Menstrual Cycle) -Magnetic resonance imaging (MRI): The subject lies in the MRI scanner, a narrow cylinder with a strong magnetic field, for imaging the uterus. -Saline hysterosonogram: This is an ultrasound examination of the uterus. A speculum is placed in the vagina and a small amount of liquid is inserted into the uterus. A probe is then inserted into the vagina. The probe emits and receives sound waves that are used to visualize the fibroids and surrounding structures. Study Drug Phase (Second through Fourth Menstrual Cycles) -Subjects are randomly assigned to take CDB-2914 or placebo (inactive compound) once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop. -Pregnancy test on first or second day of every menstrual cycle. -Blood tests every 2 weeks to measure effects of study medication on hormones, blood count, blood chemistries and liver function. -24-hour urine collections three times during the study, about once a month, to measure cortisol and check adrenal gland function. -Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth. -Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids. Surgery Women who are candidates for surgical removal of their fibroids and choose to have the surgery are admitted to the Clinical Center for a hysterectomy or myomectomy (removal of fibroids only, leaving uterus intact). Subjects hand in menstrual charts and symptom records and complete a quality-of-life questionnaire. Subjects undergo hysterectomy or myomectomy and remain in the hospital for up to 4 days after surgery. They return to the hospital for a routine checkup 4 to 6 weeks after surgery and are then returned to the care of their physician. Alternative to Surgery Women who choose not to have surgery have blood drawn and complete a quality-of-life questionnaire. They may choose to return to the care of their physician or receive CDB-2914 for 3 months, whether or not they received it during the first 3 months of the study. If they choose to take CDB-2914, they have blood tests every 2 weeks and another MRI and ultrasound at the end of the second 3 months.
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