Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
Brief Summary: This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.


Options:
A: Inclusion Criteria:

* Symptomatic uterine leiomyomata
* Reproductive age or premenopausal
* Accepting the use of non hormonal contraception
* Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
* Agreeing to have ultrasound examinations in every follow-up or evaluation visit
* Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination

Exclusion Criteria:

* Pregnancy or desire to become pregnant
* Breastfeeding
* Hormonal contraception or any hormonal therapy received in the last three months
* Signs or symptoms of pelvic inflammatory disease
* Adnexal masses
* Abnormal or unexplained vaginal bleeding
* Suspected or diagnosed malignant neoplastic disease
* Signs or symptoms of mental illness
* Adrenal disease
* Sickle cell anemia
* Hepatic disease
* Renal disease
* Coagulopathy
* Any other severe or important disease
* Any contraindication to receiving antiprogestins
B: Inclusion Criteria:

* Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
* Subject with a Body Mass Index ≥18 and ≤40.
* Subject with myomatous uterus size \< 16 weeks.
* Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
* Subject complained of strong uterine bleeding.
* Subject is eligible for hysterectomy or myomectomy.
* Females of childbearing potential have to practice a non-hormonal method of contraception.

Exclusion Criteria:

* Subject has a history of or current uterus, cervix, ovarian or breast cancer.
* Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
* Subject has a known severe coagulation disorder.
* Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
* Subject has abnormal hepatic function at study entry.
C: 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
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: D