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

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: Placebo; Drug: Telapristone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02301897

ZPU-203

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is a pre-menopausal female, between 18 and 47 years
• Participant 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 milliliters (mL) of blood loss, to ensure participants 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

• Participant 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
• Participants with abnormally high liver enzymes or liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).

Treatment:

Drug: Placebo

Telapristone Acetate 6 mg

Experimental group

Description:

Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.

Treatment:

Drug: Telapristone Acetate

Telapristone Acetate 12 mg

Experimental group

Description:

Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.

Treatment:

Drug: Telapristone Acetate