Protocol Number: 02-CH-0287
Pre-menopausal women between 33 and 50 years of age who have predictable menstrual cycles of normal length and uterine fibroids of at least 2 cm in size may be eligible for this study. Only women who need and want hysterectomy for treatment of fibroids will be enrolled. Candidates will be screened with a medical history and physical examination, including a breast and pelvic examination, blood and urine tests, and completion of a questionnaire about quality of life. They will be taught to use a kit to test their urine for LH, a hormone produced in large amounts just before ovulation, and will be given a calendar to record the LH surge, as well as any spotting, bleeding, or other symptoms. The study will take place over four menstrual cycles, after which hysterectomy will be performed. Participants will undergo the following procedures: - First (pre-treatment) cycle: Participants will undergo magnetic resonance imaging (MRI) and a special ultrasound test called saline hysterosonogram. MRI uses radio waves and a magnetic field to image body tissues. The subject lies in a narrow metal cylinder (the scanner) for about an hour during the imaging. A contrast material is injected into a vein to brighten the images. The saline hysterosonogram involves placing a speculum in the vagina, as if for a Pap test, and then putting a very small amount of liquid inside the uterus, using a small plastic tube. An ultrasound examination is then done by inserting a probe into the vagina. The probe emits and receives sound waves that are used to form a picture of the internal structures. - Second through fourth menstrual cycles - Participants will have a pregnancy test on the first or second day of each cycle. Those who are not pregnant will take CDB-2914 once a day for three menstrual cycles, or up to 102 days if the cycles are irregular. At specific times during the cycles, subject will have blood tests to measure the effect of CDB-2914 on hormones, blood count, blood chemistries, and liver function, and ultrasound tests to check the number and size of follicles in the ovaries. They will test their urine to detect the LH surge and will have additional hormone blood tests. At three times during the study-during the first, second and third menstrual cycles-subjects will bring a 24-hour urine collection to the clinic for measurements of cortisol and adrenal gland function. A transvaginal ultrasound study will be repeated after 4 to 6 weeks of treatment to check fibroid growth. A repeat saline hysterosonogram and MRI will be done within 2 weeks of surgery to count the number of fibroids and measure their size. Women who have completed the study to the end of the four menstrual cycles and still require hysterectomy will stop taking CDB-2914. They will complete another quality of life questionnaire. Their blood levels of CDB-2914 will be measured, and they will have a hysterectomy, in which the uterus, and possibly the ovaries, will be removed. Subjects will be discharged from the hospital 2 to 4 days after surgery and will return to the clinic for post-operative evaluation after 4 to 6 weeks.
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