Clinical trial NCT00740831: PGL4001 Versus GnRH-agonist in Uterine Myomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Myomas
Keywords: Uterine Myomas
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 3 months
measure: Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
timeFrame: Week 13 visit
measure: 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
timeFrame: Up to week 17
Secondary outcomes:
measure: Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Neunkirchen
country: Austria
facility: Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
city: Vienna
country: Austria
facility: Medical University Vienna
city: Brussels
country: Belgium
facility: Hopital Erasme, Department of Obstetrics and Gynecology,
city: Brussels
country: Belgium
facility: Clinique Universitaire St-Luc
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Yvoir
country: Belgium
facility: Clinique Universitaire de Mont-Godinne
city: Bordeaux
country: France
facility: Cabinet de Gynécologie Chirurgicale
city: Clermont Ferrand
country: France
facility: CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique
city: Chemnitz
country: Germany
facility: Klinik für Gynäkologie und Geburtshilfe
city: Frankfurt
country: Germany
facility: Private Practice
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
city: Köln
country: Germany
facility: Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
city: Lübeck
country: Germany
facility: Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe
city: Münster
country: Germany
facility: Poliklinik fur Frauenheilkunde und Geburtshilfe
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Westerstede
country: Germany
facility: Ammerland-Klinik GmbH Frauenklinik
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center, Division of Obstetrics & Gynecology
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Jerusalem
country: Israel
facility: Hadassah University Hospital, Mount Scopus
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital Nahariya
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Helen Schneider Hospital for Women
city: Bari
country: Italy
facility: Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari
city: Cagliari
country: Italy
facility: Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia
city: Napoli
country: Italy
facility: Policlinico Universitario Federico II
city: Padova
country: Italy
facility: Universita di Padova-Dip scienze ginecologiche e della riproduzione umana
city: Palermo
country: Italy
facility: Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Policlinico Universitario "Agostino Gemelli"
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine
city: Bialystok
country: Poland
facility: Prywatna Klinika Polozniczo-Ginekologiczna
city: Gdańsk
country: Poland
facility: INVICTA Sp. Z o.o.
city: Katowice
country: Poland
facility: Private Practice
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
city: Warszawa
country: Poland
facility: Gabinet Lekarski Specjalistyczny "Sonus"
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Lugo
country: Spain
facility: Clínica Ginecológica CEOGA
city: Madrid
country: Spain
facility: Private Practice
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena
city: Valencia
country: Spain
facility: Hospital Universitaris La Fe
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
affiliation: PregLem SA
name: Dr Elke Bestel
role: STUDY_DIRECTOR
References:
citation: Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.