Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding
Brief Summary: This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Options:
A: Inclusion Criteria:

* Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

* Subject has a large uterine polyp (\> 2cm).
* Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
* Subject has abnormal hepatic function at re-test.
* Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
* Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
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:

* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
* Negative pregnancy test
* Agrees to Double-barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
* History of Polycystic Ovary Syndrome or prolactinoma
* MRI shows significant gynecologic disorder
* Uterine size \> 25 weeks gestation
* Hemoglobin \< 8 g/dL at Day -1
D: 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.

Answer: A