CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women
- 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.
- To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.
- Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Reduce Bleeding in Premenopausal Women With Abnormal Uterine Bleeding: A Pilot Study|
- Primary outcome parameters will include bleeding symptoms evaluated by Menorrhagia Impact Questionnaire (MIQ), composite bleeding score, endometrial hyperplasia, changes in hemoglobin (g/dL)
- Quality of life as measured by surveys.
|Study Start Date:||November 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Abnormal uterine bleeding is the most common gynecologic complaint in reproductive aged women. Medical treatment of abnormal uterine bleeding has high failure rates and surgical management remains the primary, definitive therapy. Most women undergoing hysterectomy for abnormal bleeding failed a therapeutic trial of medical management. Consequently, development of an efficacious, new medical treatment for abnormal uterine bleeding is urgently needed. Many of these reproductive aged women also need contraception. Ulipristal acetate (UPA), a novel progesterone receptor modulator developed at the NIH, has promise as an effective medical treatment for abnormal uterine bleeding and as a contraceptive agent. In women with symptomatic fibroids, UPA significantly reduced fibroid size, stopped menstrual bleeding and led to an increase in red blood cell hemoglobin. It also inhibited release of an egg from the ovaries (ovulation) without reducing estrogen levels or causing hot flashes, making contraception a potential future use.
This study will evaluate UPA effects on estrogen production and ovulation, and will determine whether it reduces bleeding in women who have abnormal uterine bleeding as assessed by the Menorrhagia Impact Questionnaire (MIQ) and menstrual calendars. Women with an anatomic abnormality of the uterus are not eligible to participate. Participants will take UPA (10 mg daily by mouth) or a similar-appearing inactive pill (placebo) for approximately 90 days. Women will be randomly assigned to receive daily UPA 10 mg, or a daily placebo tablet, during the initial three-month period. The participants and the investigators will not be informed of the treatment group. To understand the effects of UPA on the uterus and its lining (endometrium), women will have studies before and at the end of UPA treatment, including ultrasound imaging of the uterus after injection of a small amount of sterile saline into the uterine cavity, and a biopsy of the endometrium to examine the tissue under the microscope. Before and while taking study agent, women will record daily bleeding and complete the MIQ monthly. During the treatment period, blood will be taken weekly to measure hormone levels (to evaluate ovulation blockage), and monthly to evaluate safety. At the end of the randomized study period, the research team will offer participants additional options of UPA or surgical therapy. Women may choose surgical therapy at the NIH or may elect other treatment options elsewhere.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493791
|Principal Investigator:||Alicia Y Armstrong, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|