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Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Reduce Bleeding in Premenopausal Women With Abnormal Uterine Bleeding: A Pilot Study

Phase 0
25 Years
50 Years
Not Enrolling
Urogenital Abnormalities

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Trial Information

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.

Inclusion Criteria


- Female gender - to evaluate effects in the target population for clinical trials

- History of abnormal uterine bleeding documented by menorrhagia impact questionnaire
(MIQ) and menstrual calendar

- Anovulatory and ovulatory women will be included

- In good health. Chronic medication use is acceptable except for glucocorticoid use.
Other chronic medication use may be acceptable at the discretion of the research
team. Interval use of over-the counter drugs is acceptable but must be recorded.

- Ovulatory women will be defined as those who have menstrual cycles of 24 - 35 days
and a progesterone value > 3.0 pg/mL between 5 and 9 days after in-home
documentation of an LH surge

- Anovulatory women will be defined as those without an in-house LH surge in whom
progesterone values 3 and 4 weeks after menses are < 3.0 ng/mL

- Hemoglobin > 10 g/dL (for those wishing surgery); iron may be administered to
improve red blood cell counts

- Willing and able to comply with study requirements

- Age 25-40

- Using mechanical (condoms, diaphragms), sterilization or abstinence methods of
contraception for the duration of the study

- Negative urine pregnancy test

- BMI less than or equal to 33, if a surgical candidate or less than or equal to 35, if
not a surgical candidate.

- Creatinine less than 1.3 mg/dL

- Liver function tests within 130 percent of upper limit

- Women who elect surgery must state that they do not desire further fertility.

- Endometrial biopsy without endometrial hyperplasia or neoplasia

- Normal cervical cytology screening within the last 12 months


- Significant abnormalities in the history, physical or laboratory examination

- Pregnancy

- Lactation

- Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year

- History of malignancy within the past 5 years

- Vaginal Bleeding in context of anatomic abnormality, endometrial neoplasia or
hyperplasia, cervical, vaginal, or vulvar neoplaisa or preneoplastic pathology

- Use of estrogen or progesterone-containing compounds, such as oral contraceptives and
hormone replacement therapy, within 8 weeks of study entry, including transdermal,
injectable, vaginal and oral preparations

- Current use of agents known to induce hepatic P450 enzymes; use of imidazoles

- Current use of GnRH analogs or other compounds that affect menstrual cyclicity

- Use of herbal medication having estrogenic or antiestrogenic effects within the past
3 months

- FSH > 20 IU/mL

- Untreated cervical dysplasia

- Need for interval use of narcotics

- Abnormal adnexal/ovarian mass

- Contradiction to anesthesia, for women planning surgery

- Leiomyomata, polyps or other anatomic causes of vaginal bleeding

- Previous participation in the study

- Thrombocytopenia defined as platelets < 150,000

- Patients with known abnormal breast pathology

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Primary outcome parameters will include bleeding symptoms evaluated by Menorrhagia Impact Questionnaire (MIQ), composite bleeding score, endometrial hyperplasia, changes in hemoglobin (g/dL)

Principal Investigator

Alicia Y Armstrong, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


United States: Federal Government

Study ID:




Start Date:

November 2011

Completion Date:

August 2014

Related Keywords:

  • Urogenital Abnormalities
  • CDB-2914
  • Abnormal Urine Bleeding
  • Abnormal Uterine Bleeding
  • Congenital Abnormalities
  • Hemorrhage
  • Urogenital Abnormalities
  • Uterine Hemorrhage



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892