Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Intervention: ulipristal acetate 20 mg; ulipristal acetate 10 mg; placebo
Intervention description: 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
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: study agents were formulated in identical looking capsules
Enrollment: 72.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Endometrium; Progesterone; Estrogen; Fibroid; Hysterectomy; Leiomyoma; Uterine Fibroids; Fibroids

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

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Female gender-to evaluate effects in the target population for clinical trials.

          -  History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as
             defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin:

          -  Excessive uterine bleeding will be evidenced by either of the following-profuse
             bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or
             anemia due to acute or chronic blood loss;

        OR

          -  Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower
             abdominal or low back pressure or bladder pressure with urinary frequency not due to
             urinary tract infection.

          -  Uterine leiomyoma(ta) of at least 2 cm size.

          -  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.

          -  Menstrual cycles of 24 - 35 days.

          -  Hemoglobin greater than 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 to 50.

          -  Using mechanical (condoms, diaphragms) sterilization or abstinence methods of
             contraception for the duration of the study.

          -  Negative urine pregnancy test.

          -  Body mass index (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% of upper limit.

          -  If interested in hysterectomy, no desire for fertility.

        EXCLUSION CRITERIA:

          -  Significant abnormalities in the history, physical or laboratory examination.

          -  Pregnancy.

          -  Lactation.

          -  Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year.

          -  Unexplained vaginal bleeding.

          -  History of malignancy within the past 5 years.

          -  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.

          -  Use of agents known to induce hepatic P450 enzymes; use of imidazoles.

          -  Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that
             affect menstrual cyclicity.

          -  Follicle stimulating hormone (FSH) greater than 20 IU/mL.

          -  Untreated cervical dysplasia.

          -  Need for interval use of narcotics.

          -  Abnormal adnexal/ovarian mass.

          -  Use of herbal medication having estrogenic or antiestrogenic effects within the past 3
             months.

          -  Contradiction to anesthesia, for women planning surgery.

          -  Genetic causes of leiomyomata.

          -  Previous participation in the study.

          -  Known recent rapid growth of fibroids, defined as a doubling in size in six months.