Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Study Overview
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Brief Summary
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Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Detailed Description
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Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Official Title
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A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: 12.5 mg Proellex
* Drug: 25 mg Proellex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound. Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain Exclusion Criteria: Post-menopausal women, as defined as one or more of the following: six months or more (immediately prior to Screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy Subjects with documented endometriosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: 12.5 mg Proellex<br>Proellex 12.5 mg daily | Drug: 12.5 mg Proellex<br>* 12.5 mg Proellex administered orally daily<br>* Other names: Telapristone acetate;|
| Experimental: 25 mg Proellex daily<br>Proellex 25 mg | Drug: 25 mg Proellex<br>* 25 mg Proellex administered orally daily<br>* Other names: Telapristone acetate;|
| Placebo Comparator: Placebo<br>Placebo daily | Drug: Placebo<br>* Administered orally daily<br>* Other names: Dummy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata |  | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata |  | 91 days | 

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