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Spots Global Cancer Trial Database for PGL4001 Versus GnRH-agonist in Uterine Myomas

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Trial Identification

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

Conditions

Uterine Myomas

Interventions

PGL4001
leuprorelin

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Dr Elke Bestel

Affiliation: PregLem SA

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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