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Brief Title: 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 ID: NCT00740831
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Medical University Graz, Graz, , Austria
Medical University of Innsbruck, Innsbruck, , Austria
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology, Neunkirchen, , Austria
Medical University Vienna, Vienna, , Austria
Hopital Erasme, Department of Obstetrics and Gynecology,, Brussels, , Belgium
Clinique Universitaire St-Luc, Brussels, , Belgium
CHR de la Citadelle, Liège, , Belgium
Clinique Universitaire de Mont-Godinne, Yvoir, , Belgium
Cabinet de Gynécologie Chirurgicale, Bordeaux, , France
CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique, Clermont Ferrand, , France
Klinik für Gynäkologie und Geburtshilfe, Chemnitz, , Germany
Private Practice, Frankfurt, , Germany
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,, Hannover, , Germany
Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe, Köln, , Germany
Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe, Lübeck, , Germany
Poliklinik fur Frauenheilkunde und Geburtshilfe, Münster, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Ammerland-Klinik GmbH Frauenklinik, Westerstede, , Germany
Soroka University Medical Center, Division of Obstetrics & Gynecology, Be'er Sheva, , Israel
Hadassah University Hospital, Jerusalem, , Israel
Hadassah University Hospital, Mount Scopus, Jerusalem, , Israel
Meir Medical Center, Kfar-Saba, , Israel
Western Galilee Hospital Nahariya, Nahariya, , Israel
Rabin Medical Center, Helen Schneider Hospital for Women, Petach Tikva, , Israel
Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari, Bari, , Italy
Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari, Cagliari, , Italy
Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia, Monza, , Italy
Policlinico Universitario Federico II, Napoli, , Italy
Universita di Padova-Dip scienze ginecologiche e della riproduzione umana, Padova, , Italy
Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone, Palermo, , Italy
Policlinico Universitario "Agostino Gemelli", Roma, , Italy
University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine, Utrecht, , Netherlands
Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok, , Poland
INVICTA Sp. Z o.o., Gdańsk, , Poland
Private Practice, Katowice, , Poland
Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii, Lublin, , Poland
Gabinet Lekarski Specjalistyczny "Sonus", Warszawa, , Poland
Institut Universitari Dexeus, Barcelona, , Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Clínic i Provincial, Barcelona, , Spain
Clínica Ginecológica CEOGA, Lugo, , Spain
Private Practice, Madrid, , Spain
Hospital Universitario Doce de Octubre, Madrid, , Spain
Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena, Murcia, , Spain
Hospital Universitaris La Fe, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Name: Dr Elke Bestel
Affiliation: PregLem SA
Role: STUDY_DIRECTOR