PGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)

December 13, 2012 updated by: PregLem SA

A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

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
      • Graz, Austria, 8036
        • Medical University Graz
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck
      • Neunkirchen, Austria, 2620
        • Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
      • Vienna, Austria, 1090
        • Medical University Vienna
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Erasme, Department of Obstetrics and Gynecology,
      • Brussels, Belgium, 1200
        • Clinique Universitaire St-Luc
      • Liège, Belgium, 4000
        • CHR de la Citadelle
      • Yvoir, Belgium, 5530
        • Clinique Universitaire De Mont-Godinne
  • France
      • Bordeaux, France, 33000
        • Cabinet de Gynécologie Chirurgicale
      • Clermont Ferrand, France, 63058
        • CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
  • Germany
      • Chemnitz, Germany
        • Klinik für Gynäkologie und Geburtshilfe
      • Frankfurt, Germany, 60322
        • Private Practice
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
      • Köln, Germany, 50931
        • Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
      • Lübeck, Germany, 23538
        • Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
      • Münster, Germany, 48149
        • Poliklinik fur Frauenheilkunde und Geburtshilfe
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
      • Westerstede, Germany, 26655
        • Ammerland-Klinik GmbH Frauenklinik
  • Israel
      • Be'er Sheva, Israel, 84101
        • Soroka University Medical Center, Division of Obstetrics & Gynecology
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
      • Jerusalem, Israel
        • Hadassah University Hospital, Mount Scopus
      • Kfar-Saba, Israel
        • Meir Medical Center
      • Nahariya, Israel, 22100
        • Western Galilee Hospital Nahariya
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center, Helen Schneider Hospital for Women
  • Italy
      • Bari, Italy
        • Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
      • Cagliari, Italy
        • Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
      • Monza, Italy
        • Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
      • Napoli, Italy
        • Policlinico Universitario Federico II
      • Padova, Italy
        • Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
      • Palermo, Italy, 70100
        • Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
      • Roma, Italy, 00168
        • Policlinico Universitario "Agostino Gemelli"
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
  • Poland
      • Bialystok, Poland, 15-224
        • Prywatna Klinika Polozniczo-Ginekologiczna
      • Gdańsk, Poland, 80-895
        • INVICTA Sp. Z o.o.
      • Katowice, Poland, 40-084
        • Private Practice
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
      • Warszawa, Poland, 02-066
        • Gabinet Lekarski Specjalistyczny "Sonus"
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
      • Barcelona, Spain, 08028
        • Institut Universitari Dexeus
      • Lugo, Spain, 27002
        • Clinica Ginecologica CEOGA
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de Octubre
      • Madrid, Spain, 28009
        • Private Practice
      • Murcia, Spain, 30120
        • Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
      • Valencia, Spain, 46017
        • Hospital Universitario Dr. Peset
      • Valencia, Spain, 46009
        • Hospital Universitaris La Fe

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 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be a pre-menopausal woman between 18 and 50 years inclusive.
  • Have excessive uterine bleeding due to myoma
  • Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
  • Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.
  • Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
  • Has a known severe coagulation disorder.
  • Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
  • Has a history of or known current osteoporosis.
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
  • Has a current (within twelve months) problem with alcohol or drug abuse.
  • Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A (PGL4001 5 mg)
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Drug: PGL4001
tablets
Other Names:
  • Ulipristal acetate
EXPERIMENTAL: B (PGL4001 10mg)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Drug: PGL4001
tablets
Other Names:
  • Ulipristal acetate
ACTIVE_COMPARATOR: C (GnRH-agonist)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
Drug: leuprorelin
solution for injection
Other Names:
  • GnRH-agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
Time Frame: 3 months

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

The week 13 PBAC score was calculated using the last 28 days of treatment.
3 months
Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
Time Frame: Week 13 visit
Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
Week 13 visit
Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
Time Frame: Up to week 17

Difference in percentage of subjects reporting moderate or severe hot flushes:

Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
Up to week 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
Time Frame: 3 months

Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.

The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).
3 months

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

August 1, 2008

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (ESTIMATE)

August 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGL07-022

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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