Urogenital Abnormalities Clinical Trial
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
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....
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.
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