CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women
Status:
Withdrawn
Trial end date:
2013-07-24
Target enrollment:
Participant gender:
Summary
Background:
- CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining
pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual
periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in
women with fibroids, it may be able to treat abnormal periods in women without fibroids.
Objectives:
- To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.
Eligibility:
- Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have blood and urine tests. An ultrasound with fluid of the uterus will test for
fibroids. Uterine cells will be collected for biopsy.
- For the next three menstrual cycles, participants will take either CDB-2914 or a
placebo. Treatment will be studied with blood tests and symptom diaries.
- At the end of the treatment, participants have three options. They can have surgery at
the Clinical Center or have another 3 months of CDB-2914. The third option is to stop
treatment at the Clinical Center.
- Surgery will be either uterine ablation or hysterectomy. Only women older than age 33
may have a hysterectomy. Blood and urine samples will be collected after surgery.
- Both surgery and further treatment participants will have followup exams.
- All participants will have a final followup exam 1 year after stopping treatment....
Phase:
Early Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)