MedTrace Logo

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

NCT02811159 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-06-27

Study results available
· View outcomes & findings →

Summary

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Telapristone acetate

Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Chan · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-26
Primary Completion
2017-05-04
Completion
2017-05-04

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811159 on ClinicalTrials.gov