Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

Study Overview
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Brief Summary
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The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Detailed Description
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Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Official Title
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A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Conditions
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Uterine Fibroids

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak, read and understand English or Spanish; Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study; One uterine fibroid must be identifiable and measurable by transvaginal ultrasound; Menstrual cycle lasting from 24 to 36 days; History of excessive menstrual bleeding; Negative urine pregnancy test at screening. Additional inclusion criteria may apply. Exclusion Criteria: Six months or more (immediately prior to Screening Visit) without a menstrual period; Prior hysterectomy; Prior bilateral oophorectomy; Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study; Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease; Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV); Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system; Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies. Additional exclusion criteria may apply.

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25 mg Proellex<br>Proellex 25 mg once daily | Drug: Proellex 25 mg<br>* One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle<br>* Other names: Telapristone acetate;|
| Active Comparator: Proellex 50 mg<br>Proellex 50 mg once daily | Drug: Proellex 50 mg<br>* Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle<br>* Other names: Telapristone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Fibroids