Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2008-08-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A (PGL4001 5 mg)
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
PGL4001
tablets
B (PGL4001 10mg)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
PGL4001
tablets
C (GnRH-agonist)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
leuprorelin
solution for injection
Interventions
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PGL4001
tablets
leuprorelin
solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
FEMALE
No
Sponsors
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PregLem SA
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Elke Bestel
Role: STUDY_DIRECTOR
PregLem SA
Locations
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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
Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe
Cologne, , Germany
Private Practice
Frankfurt, , Germany
Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,
Hanover, , 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
Beersheba, , 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
Petah 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
Padua, , 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.
Gdansk, , Poland
Private Practice
Katowice, , Poland
Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii
Lublin, , Poland
Gabinet Lekarski Specjalistyczny "Sonus"
Warsaw, , 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
Countries
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References
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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.
Other Identifiers
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PGL07-022
Identifier Type: -
Identifier Source: org_study_id