PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

January 12, 2016 updated by: PregLem SA

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna, department of obstetrics and gynecology
  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
      • Liège, Belgium, 4000
        • CHR de la Citadelle Gynécologie-Obstétrique
      • Yvoir, Belgium, 5530
        • Cliniques Universitaires UCL de Mont-Godinne Gynécologie-Obstétrique
  • 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
        • Private Practice
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Klinika Ginekologii Onkologicznej i Ginekologii
      • Warszawa, Poland, 00-815
        • Private Practice
      • Warszawa, Poland, 02-066
        • Private Practice
      • 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 Hebron, gynecology department
      • Lugo, Spain, 27002
        • Clinica Ginecologica CEOGA, departamento de Ginecologia
      • Madrid, Spain, 28009
        • Private Practice
      • Madrid, Spain, 28041
        • HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre Departamento de Ginecología
      • Malaga, Spain, 29010
        • CHIP (Complejo Hospitalario Integral Privado)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

  • Subject has a large uterine polyp (> 2cm).
  • Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
  • Subject has abnormal hepatic function at re-test.
  • Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
  • Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ended by a drug free period until return of menses.
Drug: PGL4001, placebo, drug free period
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.
Other Names:
  • Ulipristal acetate
Experimental: B
PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets) during 3 periods each ended by a drug free period until return of menses.
Drug: PGL4001, progestin, drug free period
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets) during 3 periods each ending with a drug free period until return of menses.
Other Names:
  • Ulipristal acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
Time Frame: From baseline to end of each PGL4001 treatment (3months treatment)
From baseline to end of each PGL4001 treatment (3months treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PregLem SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGL09-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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