A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
NCT ID: NCT01635452
Last Updated: 2015-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1500 participants
OBSERVATIONAL
2012-05-31
2016-03-31
Brief Summary
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The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients treated with Esmya
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient is breastfeeding,
* Patient has genital bleeding of unknown etiology or not due to uterine fibroids,
* Patient has been diagnosed with uterine, cervical, ovarian or breast cancer,
* Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment,
* Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients
18 Years
FEMALE
No
Sponsors
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PregLem SA
INDUSTRY
Responsible Party
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Principal Investigators
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Jaime Oliver, MD
Role: STUDY_DIRECTOR
PregLem SA
Locations
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LKH Klagenfurt
Klagenfurt, , Austria
Private practice
Sankt Pölten, , Austria
CHU Pellegrin Gynécologie
Bordeaux, , France
Hopital Bicetre
Le Kremlin-Bicètre, , France
CHU La Conception
Marseille, , France
CHU Hôpital Mère-enfant
Nantes, , France
Tenon CHU Paris Est
Paris, , France
CHUV Maison Blanche Institut
Reims, , France
CHU Anne de Bretagne
Rennes, , France
CHU Tours Gynécologie
Tours, , France
Universitätsklinikum Aachen
Aachen, , Germany
Klinik am Hofgarten
Bayreuth, , Germany
Charite
Berlin, , Germany
Private practice
Berlin, , Germany
Medizinisches Zentrum Bonn Friedensplatz
Bonn, , Germany
Private Practice
Bruchsal, , Germany
Private practice
Cologne, , Germany
Private Practice
Diepholz, , Germany
Private practive
Dorsten, , Germany
Private practice
Dortmund, , Germany
Frauenklinik, Universitätsklinikum Erlangen
Erlangen, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Universitäts Frauenklinik
Freiburg im Breisgau, , Germany
Gynäkologische Praxis
Geseke, , Germany
Hormonzentrum Altonaerstrasse
Hamburg, , Germany
Gynaekologische Praxisklinik Harburger Ring
Harburg, , Germany
Private practice
Hoyerswerda, , Germany
Private practice
Ilsede, , Germany
Private practice
Krefeld, , Germany
Gynäkologische Praxis
Mainz, , Germany
Endoskopie und Endometriose Zentrum
München, , Germany
Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde
München, , Germany
Private practice
Rodgau, , Germany
Fachaerzte fuer Frauenheilkunde und Geburtshilfe
Rotenburg (Wümme), , Germany
Private practice
Völklingen, , Germany
Semmelweis University Faculty of Medicine
Budapest, , Hungary
University of Pécs Medical school
Pécs, , Hungary
Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi
Bologna, , Italy
Universita di Cagliari
Cagliari, , Italy
Azienda Ospedaliera Garibaldi-Nesima
Catania, , Italy
Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna
Cona, , Italy
Università degli Studi di Firenze
Florence, , Italy
Clinica ospedale san martino e cliniche universitarie convenzionate di genova
Genova, , Italy
IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano
Milan, , Italy
La Sapienza University
Roma, , Italy
Ospedale Mauriziano "Umberto I"
Torino, , Italy
Private practice
Kętrzyn, , Poland
Private practice
Komorów, , Poland
Private practice
Lublin, , Poland
Private Practice
Opole, , Poland
Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa
Płock, , Poland
Centrum Zdrowia mama i Ja
Wroclaw, , Poland
Gabinet Ginekologiczny
Żory, , Poland
Hospital do Espirito santo de Évora
Evora, , Portugal
Hospital da Luz-Lisboa
Lisbon, , Portugal
Spitalul Clinic de Urgenta Militar Central
Bucharest, , Romania
OG Clinic II " Dominic Stanca "
Cluj-Napoca, , Romania
Spitalul Clinic de Urgenta
Târgu Mureş, , Romania
Hospital del Mar
Barcelona, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital de la Zarzuela
Madrid, , Spain
Hospital Virgen de la Macarena
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Bradford Royal Infirmary
Bradford, , United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, , United Kingdom
Hull and East Yorshire Eye Hospital
East Yorkshire, , United Kingdom
Epsom & St Helier University Hospitals NHS Trust
Epsom Surrey, , United Kingdom
Royal devon and Exeter hospital
Exeter, , United Kingdom
Royal Hampshire County Hospital
Hampshire, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Liverpool Womens hospital
Liverpool, , United Kingdom
Barts and The London School of Medicine
London, , United Kingdom
King's College Hospital NHS Foundation
London, , United Kingdom
Nottingham University Hospital NHS trust
Nottingham, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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References
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Fernandez H, Descamps P, Koskas M, Lopes P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.
Other Identifiers
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PGL10-014
Identifier Type: -
Identifier Source: org_study_id
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