Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
NCT ID: NCT02748460
Last Updated: 2025-09-02
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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COMPLETED
1527 participants
OBSERVATIONAL
2015-12-22
2024-04-11
Brief Summary
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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
Any patient who was confirmed as receiving one dose of Esmya
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and
* Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study.
Exclusion Criteria
* Patient has a contraindication to receive Esmya as per SmPC
* Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,
* Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,
* Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:
* Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,
* Patient is breastfeeding,
* Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,
* Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.
18 Years
FEMALE
No
Sponsors
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PregLem SA
INDUSTRY
Responsible Party
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Principal Investigators
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Pablo Arriagada
Role: STUDY_DIRECTOR
PregLem SA
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier Regional De La Citadelle
Liège, , Belgium
Clinique Universitaire de Mont Godinne
Yvoir, , Belgium
Dr Dvorak
Brno, , Czechia
Gyn-Porodnicka Klinika Fn Brno
Brno, , Czechia
Gyn -Fsro
Králová, , Czechia
G-Centrum Olomouc S.R.O.
Olomouc, , Czechia
Private Practice 2
Prague, , Czechia
Private Practice
Prague, , Czechia
Uherskohradistska Nemocnice A.S
Uherské Hradiště, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Gastroenheden Herlev-Gentofte
Herlev, , Denmark
Centre Hospitalier Universitaire d'Angers
Angers, , France
Centre Hospitalier de Bethune
Béthune, , France
Groupement Hospitalier Universitaire Sud CHU Bicetre
Le Kremlin-Bicêtre, , France
Hopital Bichat - Claude-Bernard
Paris, , France
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
Tours, , France
Private practice
Aachen, , Germany
Klinikum Bayreuth GmbH
Bayreuth, , Germany
Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert
Berlin, , Germany
Gynakologische Praxis Klinik
Bonn, , Germany
PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie
Cologne, , Germany
Gemeinschaftspraxis der Frauenarztpraxis
Deggendorf, , Germany
Private Practice
Dortmund, , Germany
Private Practice
Frankfurt, , Germany
Frauenarztpraxis
Frankfurt am Main, , Germany
Hellweg gynakologie/DOCX
Geseke, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Frauenarztpraxis Gluckstadt
Glückstadt, , Germany
Frauenarzt Bergedorf
Hamburg, , Germany
Frauenarztpraxis Wandsbek
Hamburg, , Germany
Praxisklinik Harburg
Hamburg, , Germany
Private Practice
Hamburg, , Germany
Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie
Hamburg, , Germany
Private practice
Ilsede, , Germany
Frauenarztpraxis
Köthen, , Germany
Medplus Krefeld
Krefeld, , Germany
Endoskopie Und Endometriose-Zentrum Munchen
München, , Germany
Private Practice
Plöcking, , Germany
Private practice
Ribnitz-Damgarten, , Germany
Private Practice
Stolberg, , Germany
Ammerland Klinik GmbH
Westerstede, , Germany
Rethy Pal Hospital-Clinic Bekescsaba
Békéscsaba, , Hungary
Robert Karoly Maganklinika
Budapest, , Hungary
Szent Anna Privat Surgery-Szent Anna Magae¡nrendela
Debrecen, , Hungary
Josa Andras County Teaching Hospital
Nyíregyháza, , Hungary
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
Szeged, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche
Ancona, , Italy
University of Bari Policlinico
Bari, , Italy
Azienda Usl Di Bologna
Bologna, , Italy
Policlinico S. Orsola Malpighi
Bologna, , Italy
A.O.Spedali Civili di Brescia
Brescia, , Italy
University ""Magna Graecia"" Of Catanzaro
Catanzaro, , Italy
Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte
Siena, , Italy
University of Torino, S. Anna Hospital- City of Health and Science
Torino, , Italy
ARS
Riga, , Latvia
Latvian Maritime Medicine Centre
Riga, , Latvia
N. Lietuviete Private Practice
Riga, , Latvia
Private Practice
Riga, , Latvia
RiGa 1st Hospital
Riga, , Latvia
Jsc Kardiolita
Vilnius, , Lithuania
Medical Center Maxmeda
Vilnius, , Lithuania
Radboud Universitair Medical Center
Nijmegen, , Netherlands
Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw
Warsaw, , Poland
Centro hospitalar do Baixo vouga, EPE
Aveiro, , Portugal
Private Practice
Coimbra, , Portugal
Clinica Jardim das Amoreiras
Lisbon, , Portugal
Centrul Medical Euromed
Bucharest, , Romania
Genesys Fertility Center
Bucharest, , Romania
Spitalul Clinic Dr. Ioan Cantacuzino
Bucharest, , Romania
Elena Doamna Obstetrics and Gynecology Clinical Hospital
Iași, , Romania
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Hospitalet CSI
Barcelona, , Spain
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario de Guadalajara (HUG)
Guadalajara, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Instituto Palacios, Salud y Medicina de la Mujer
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Quironsalud Toledo
Toledo, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Danderyds Sjukhus AB
Stockholm, , Sweden
Karolinska Institutet, Karolinska University Hospital Huddinge
Stockholm, , Sweden
Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
Bath, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
University Hospital of North Durham
Durham, , United Kingdom
London North West Healthcare NHS Trust
Harrow, , United Kingdom
Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital
Huntingdon, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Queen Charlotte's & Chelsea Hospital
London, , United Kingdom
Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, , United Kingdom
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Rosemere Cancer Centre - Royal Preston Hospital
Preston, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust
Stockton-on-Tees, , United Kingdom
Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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PGL14-001 (PREMIUM)
Identifier Type: -
Identifier Source: org_study_id
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