Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in
pre-menopausal women that may cause bleeding, pelvic pain and pressure. Because fibroids
grow in the presence of estrogen, medical therapies that decrease estrogen levels (like
Gonadotropin releasing hormone,GnRH analog) cause fibroids to shrink and so may relieve
symptoms. However, such medication can only be given short-term and has inconvenient side
effects such as hot-flashes. Thus, many women with symptomatic fibroids choose to have them
removed surgically, either individually or by removing the uterus via hysterectomy.
Women between 25 and 50 years of age who have regular menstrual cycles and a history of
uterine fibroids that cause heavy bleeding, pressure, or pain may be eligible for this
study. Candidates are screened with a medical history and physical examination, including
breast and pelvic examination, blood and urine tests, a quality-of-life questionnaire, and a
home urine test for leuteinizing hormone (LH) surge. They are given a diary to record the LH
surge, days of vaginal spotting or bleeding, and symptoms. Participation includes the
following:
Baseline Studies (First Menstrual Cycle)
- Magnetic resonance imaging (MRI): The subject lies in the MRI scanner, a narrow
cylinder with a strong magnetic field, for imaging the uterus.
- Saline hysterosonogram: This is an ultrasound examination of the uterus. A speculum is
placed in the vagina and a small amount of liquid is inserted into the uterus. A probe
is then inserted into the vagina. The probe emits and receives sound waves that are
used to visualize the fibroids and surrounding structures.
Study Drug Phase (Second through Fourth Menstrual Cycles)
- Subjects are randomly assigned to take ulipristal acetate or placebo (inactive
compound) once a day by mouth on an empty stomach for three menstrual cycles or up to
102 days if menstrual cycles are irregular or stop.
- Pregnancy test on first or second day of every menstrual cycle.
- Blood tests every 2 weeks to measure effects of study medication on hormones, blood
count, blood chemistries and liver function.
- 24-hour urine collections three times during the study, about once a month, to measure
cortisol and check adrenal gland function.
- Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.
- Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the
fibroids. or placebo (inactive compound) once a day by mouth on an empty stomach for
three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop.
- Pregnancy test on first or second day of every menstrual cycle.
- Blood tests every 2 weeks to measure effects of study medication on hormones, blood
count, blood chemistries and liver function.
- 24-hour urine collections three times during the study, about once a month, to measure
cortisol and check adrenal gland function.
- Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.
- Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the
fibroids. or placebo (inactive compound) once a day by mouth on an empty stomach for
three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop.
- Pregnancy test on first or second day of every menstrual cycle.
- Blood tests every 2 weeks to measure effects of study medication on hormones, blood
count, blood chemistries and liver function.
- 24-hour urine collections three times during the study, about once a month, to measure
cortisol and check adrenal gland function.
- Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.
- Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the
fibroids.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Shrinkage of Fibroids - Size of Fibroids
The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.
3 months (baseline to end of treatment)
No
Lynnette K Nieman, MD
Principal Investigator
NICHD, NIH
United States: Food and Drug Administration
060090
NCT00290251
February 2006
August 2010
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
NIH Clinical Center | Bethesda, Maryland 20892 |