An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Telapristone acetate
Intervention description: Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No

Summary:

      To determine the safety of extended treatment with Proellex® in women who have successfully
      completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility
      criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897]

          -  Agreement not to attempt to become pregnant during the trial

          -  Agreement to use alcohol in moderation and record the daily consumption (note:
             elevated liver enzymes may result in discontinuation from the study)

          -  Ability to complete a daily subject diary and study procedures in compliance with the
             protocol

          -  Women of child-bearing potential must be willing to use double-barrier contraception
             during the study and off-drug intervals. Acceptable double-barrier methods are: male
             condom with spermicide; male condom with diaphragm; diaphragm containing spermicide
             plus additional intra-vaginal spermicide

          -  Has a negative pregnancy test at Visit 1

          -  Subject is available for all treatment and follow-up visits

        Exclusion Criteria:

          -  Subject had a significant decrease in bone mineral density while participating in
             ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)

          -  Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in
             ZPV-201 or ZPU-203

          -  Subject is pregnant or lactating or is attempting or expecting to become pregnant
             during the entire study period

          -  Subjects with abnormally high liver enzymes or liver disease. [alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit
             of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on
             repeat].

          -  Subject has a hemoglobin of <7.5 grams per deciliter (g/dL) at Visit 1

          -  Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
             dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit
             1

          -  Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in
             the preceding 10 months

          -  Use of Gonadotrophin releasing hormone agonist (GnRHas) (e.g. Lupron Depot) within 3
             months prior to screening (Lupron Depot must have a wash-out period of 3 months prior
             to screening)

          -  Has an intra-uterine device (IUD) in place

          -  Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined
             Significance (ASCUS) associated with high-risk human papilloma virus (HPV)

          -  Current diagnosis of Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL),
             endometrial polyps or hyperplasia

          -  Observation or history of abnormal endometrial biopsy including the presence of
             endometrial intraepithelial neoplasia (EIN)

          -  Recent history (within past 6 months) of alcoholism or drug abuse

          -  Endometrial stripe ≥18 mm in thickness at Visit 1 (subject may be enrolled with
             sponsor approval)

          -  Subject is currently taking cimetidine or spironolactone or has taken them in the last
             30 days

          -  Clinically significant abnormal findings on Visit 1 examination and laboratory
             assessments or any condition which in the opinion of the investigator would interfere
             with the subject's ability to comply with the study instructions or endanger the
             subject if she took part in the study.