Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

Study Overview
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Brief Summary
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Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed Description
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Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Official Title
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A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of 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
* Drug: Proellex
* Drug: Placebo


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. 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.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25 mg Proellex<br>25 mg oral daily dose of Proellex | Drug: Proellex<br>* One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months<br>* Other names: Telapristone acetate;|
| Active Comparator: 50 mg Proellex<br>50 mg oral daily dose of Proellex | Drug: Proellex<br>* Two 25 mg mg capsules of Proellex® orally daily for up to four months<br>* Other names: Telapristone acetate;|
| Placebo Comparator: placebo<br>oral daily dose of placebo | Drug: Placebo<br>* Two placebo capsules orally daily for up to four months<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC) |  | 4 months | 

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