Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Detailed Description
-----------------
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Official Title
-----------------
A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy

Conditions
-----------------
Uterine Fibroids, Anemia

Intervention / Treatment
-----------------
* Drug: Proellex 25 mg
* Drug: Proellex 50 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive; Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding; Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study; Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits Exclusion Criteria: Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following: Six months or more (immediately prior to Screening Visit) without a menstrual period, or Prior hysterectomy, or Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring); Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause; Documented endometriosis or active pelvic inflammatory disease (PID); Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs; Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia; Use of prohibited concomitant medications: Depo-Provera use must cease ten months prior to first dose of study drug, or GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg Proellex<br>Proellex 25 mg | Drug: Proellex 25 mg<br>* Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months<br>* Other names: Telapristone acetate;|
| Experimental: Proellex 50 mg<br>Proellex 50 mg | Drug: Proellex 50 mg<br>* Proellex 50 mg, 2 - 25 mg capsules daily for 3 months<br>* Other names: Telapristone acetate;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo, 2 capsules daily for 3 months<br>* Other names: Dummy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Uterine fibroids