PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLext2)

A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding

This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).

This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Ulipristal Acetate - open label

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
  • Liège, Belgium, 4000
    • CHR de la Citadelle
  • Yvoir, Belgium, 5530
    • Cliniques Universitaires UCL de Mont-Godinne
• Poland
  • Bialystok, Poland, 15-224
    • Prywatna Klinika Polozniczo-Ginekologiczna
  • Gdańsk, Poland, 80-895
    • INVICTA Sp. Z o.o.
  • Katowice, Poland, 40-724
    • Private Practice
  • Lodz, Poland, 90-602
    • Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia
  • Lublin, Poland, 20-064
    • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Warszawa, Poland, 02-066
    • Gabinet Lekarski Specjalistyczny "Sonus"
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
  • Wroclaw, Poland, 50-369
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal
  • Lugo, Spain, 27002
    • Clinica Ginecologica CEOGA
  • Madrid, Spain, 28009
    • Private Practice
  • Madrid, Spain, 28041
    • HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subject completed visit F - Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
• Females of childbearing potential are advised to practice a non-hormonal method of contraception.

Exclusion Criteria:

• Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
• Subject has taken or is likely to require treatment during the study with drugs that are not permitted by the study protocol.
• Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
• Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject's safety or interfere with study evaluations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulipristal Acetate (PGL4001) 10mg; Ulipristal Acetate (PGL4001)10mg daily administration	Drug: Ulipristal Acetate - open label; Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.; Other Names: PGL4001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire	Average score of the first 3 questions.	9 months
Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire	Average score of the first 3 questions.	18 months

Collaborators and Investigators

• Sponsor: PregLem SA
• Investigators: Study Director: Elke Bestel, Dr, PregLem SA

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: PGL11-024