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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ZPE-201 Extension of treatment

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

NCT00556075

Endometriosis

TERMINATED PHASE2

Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

NCT00958334

Uterine Fibroids

COMPLETED PHASE2

Open-Label Extension Study to ZPE-202

NCT01961908

Endometriosis

WITHDRAWN PHASE2

Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

NCT00882258

Uterine Fibroids

COMPLETED PHASE2

Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis

NCT01728454

Endometriosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Proellex®

25 mg Proellex®

Group Type EXPERIMENTAL

Proellex®

Intervention Type DRUG

one (1) 25 mg capsule daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Proellex®

one (1) 25 mg capsule daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CDB-4124

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.