Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

Phase 2TerminatedNCT00958412

Repros Therapeutics Inc.18 enrolled

Overview

ZPE-201 Extension of treatment

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis

Interventions

Proellex®DRUG

one (1) 25 mg capsule daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Only subjects treated in the ZPE-201 study will be allowed to enter the extension study. * Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate. Exclusion Criteria: * All other subjects

Locations (8)

Advanced Clinical Therapeutics, LLC

Tucson, Arizona, United States

Medical Center for Clinical Research

San Diego, California, United States

Compass Clinical Research

San Ramon, California, United States

Comprehensive Clinical Trials

Outcomes

Primary Outcomes

To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily

Number of participants who experienced 1 or more adverse event.

Time frame: 6 months

Data from ClinicalTrials.gov

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