Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine
      fibroids in pre-menopausal women.
    

Detailed description: 
      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.
    

Intervention name(s): ulipristal acetate 20 mg; ulipristal acetate 10 mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic; 10 mg given daily for three menstrual cycles or 90 - 102 days; placebo given once daily for 3 menstrual cycles or 90 - 102 days
Other intervention name(s): VA2914; CDB-2914; VA2914; CDB2914
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were studied during a single baseline menstrual cycle followed by a cross-over into three arms (active treatment at one of two doses, or placebo) given for three menstrual cycles
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endometrium; Progesterone; Estrogen; Fibroid; Hysterectomy; Leiomyoma; Uterine Fibroids; Fibroids