Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Reduce Bleeding in Premenopausal Women With Abnormal Uterine Bleeding: A Pilot Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome parameters will include bleeding symptoms evaluated by Menorrhagia Impact Questionnaire (MIQ), composite bleeding score, endometrial hyperplasia, changes in hemoglobin (g/dL)
Alicia Y Armstrong, M.D.
Principal Investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
United States: Federal Government
120015
NCT01493791
November 2011
August 2014
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |