A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 47
Updated:8/2/2018
Start Date:December 31, 2014
End Date:June 30, 2017

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A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

The primary objective of this study is to determine the safety and efficacy of two oral doses
of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by
an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.


Inclusion Criteria:

- Is a pre-menopausal female, 18-47

- Subject has a history of at least 3 regular menstrual cycles in which menorrhagia
(heavy bleeding) is due to uterine fibroids

- Confirmed uterine fibroid(s) at screening

- Visit 1 historical pictorial blood loss assessment chart of >120 mL of blood loss, to
ensure subjects have a menstrual blood loss of at least 80 mL by Alkaline Hematin
Assay (during the baseline assessment period).

- A Body Mass Index (BMI) between 18 and 45 inclusive

Exclusion Criteria:

- Subject is pregnant or lactating or is attempting or expecting to become pregnant
during the entire study period

- Received an investigational drug in the 30 days prior to the screening for this study

- Has an intrauterine device in place

- Observation or history of abnormal endometrial biopsy including the presence of
endometrial intraepithelial neoplasia

- Subjects with abnormally high liver enzymes or liver disease.
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Summerville, South Carolina 29485
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