Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Control Trial Of Mifepristone for Fibroids
Brief Summary: The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.


Options:
A: Inclusion Criteria:

* Be a pre-menopausal woman between 18 and 50 years inclusive.
* Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
* Have FSH levels ≤ 20 mIU/mL
* Have excessive uterine bleeding due to myoma.
* Have regular menstrual cycles
* Have a myomatous uterus \< 16 weeks with at least one myoma ≥ 3 cm in diameter.
* If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

* Has a history of or current uterine, cervical, ovarian or breast cancer.
* Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
* Has a known severe coagulation disorder.
* Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
* Has abnormal hepatic function at study entry.
* Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
* Has a current (within twelve months) problem with alcohol or drug abuse.
* Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
B: Inclusion Criteria:

* Gender: Female
* Age: 18 - premenopausal
* Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
* Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is =\> 2.5cm in size
* Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
* Declined standard treatment options for symptomatic fibroids
* Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately
* Willing and able to give informed consent
* Willing and able to comply with study requirements

Exclusion Criteria:

* Current or planned pregnancy during the study period
* Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
* Currently breast-feeding
* Untreated abnormal pap smear
* Presence of conditions other than fibroids contributing to pain and/or bleeding
* Hemoglobin \< 9.0 mg/dl
* Presence of adnexal masses or tenderness indicating further evaluation or surgery
* Grade III or IV hydronephrosis by ultrasound
* Severe, active mental health disorder
* Active substance abuse or dependence
* Presence of any contraindication to mifepristone including:

  * Adrenal insufficiency by history
  * Sickle cell disease
  * Active liver disease (liver function tests greater than 1.5 times upper range of normal)
  * Severe, respiratory disease (P02 saturation\< 92%)
  * Renal disease (serum creatinine \> 1.5 mg/dl)
  * Blood clotting defect. (abnormal PT and PTT)
  * Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)
* Current or recent (within the past 3 months) use of the following medications:

  * Oral or systemic corticosteroids
  * Hormones: estrogens, progestins, oral contraceptives
  * Danazol, anticoagulants
* Herbal or botanical supplements with possible hormonal effects.
* Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera.
* Current or planned use during the study of any of the following medications/or products:

  * ketoconazole,
  * itraconazole,
  * erythromycin,
  * grapefruit juice,
  * rifampin,
  * St John's Wort,
  * phenytoin,
  * phenobarbital, or
  * carbamazepine
C: 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.
D: Inclusion Criteria:

* Women between 18 and 49 years of age
* Diagnosis of either 1 or more uterine fibroids
* History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to or current use of hormone therapy
* History of osteoporosis or other bone disease
* History of uterine artery embolization, cryomyolysis, or electrical myolysis
* Subject currently breast feeding
* Hemoglobin \< 8 g/dL at baseline

Answer: B