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

Repros Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Endometriosis

Treatments: Drug: Proellex®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958412

ZPE-201 EXT

Details and patient eligibility

About

ZPE-201 Extension of treatment

Full description

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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Proellex®

Experimental group

Description:

25 mg Proellex®

Treatment:

Drug: Proellex®