Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Phase 3TerminatedNCT01069120

Repros Therapeutics Inc.27 enrolled

Overview

Safety and efficacy study of 25 and 50 mg doses of Proellex

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Fibroids

Interventions

ProellexDRUG

2, 25 mg capsules once per day

ProellexDRUG

1, 25 mg capsule once per day

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU) * Subject has a menstrual cycle lasting from 20 to 40 days. * Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304 Exclusion Criteria: * Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304. * Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Locations (4)

Visions Clinical Research

Boynton Beach, Florida, United States

Insignia Clinical Research (Tampa Bay Women's Center)

Tampa, Florida, United States

Advances in Health Inc

Houston, Texas, United States

The Women's Hospital of Texas, Clinical Research Center

Houston, Texas, United States

Outcomes

Primary Outcomes

To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)

Time frame: During two 4 month treatment periods

Data from ClinicalTrials.gov

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