Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Study Overview
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Brief Summary
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PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Detailed Description
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The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Official Title
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A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response

Conditions
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Uterine Fibroids

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding Regular or steady menstrual cycle lasting from 24 to 36 days Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug Exclusion Criteria: Documented endometriosis or active pelvic inflammatory disease History of alcohol and/or drug abuse Any history or diagnosis of gynecological cancer or cervical dysplasia Use of an IUD Use of prohibited concomitant medications: Use of Depo-Provera must cease 10 months prior to first dose of study drug Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proellex 25 mg<br>Proellex 25 mg | Drug: Proellex 25 mg<br>* Proellex 25 mg, 1 capsule daily for 4 months<br>* Other names: Telapristone acetate;|
| Experimental: Proellex 50 mg<br>Proellex 50 mg | Drug: Proellex 50 mg<br>* Proellex 50 mg, 2 capsules daily for 4 months<br>* Other names: Telapristone acetate;|
| Active Comparator: Lupron<br>Lupron Depot | Drug: Lupron Depot<br>* Lupron 3.75 mg monthly intramuscular injections for 4 months<br>* Other names: Leuprolide acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex. |  | 4 months | 

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