Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

Study Overview
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Brief Summary
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Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Detailed Description
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Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Official Title
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A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Proellex
* Drug: Proellex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU) Subject must have uterine fibroid-associated symptoms during the-screening visit Subject has menstrual cycle lasting from 20 to 40 days Other inclusion criteria may apply Exclusion Criteria: Post-menopausal women or women likely to become post-menopausal during the study Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study. Subject who has had an acute illness within five days of study medication administration Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN) Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: 25 mg<br>25 mg Proellex | Drug: Proellex<br>* One 25mg capsule taken orally once every day.<br>* Other names: Telapristone acetate;|
| Experimental: 50 mg<br>50 mg Proellex | Drug: Proellex<br>* Two 25mg capsules Proellex (50mg) taken orally once every day<br>* Other names: Telapristone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles |  | Four months each cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids |  | Two, 4 month cycles | 

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