Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
- Conditions
- Uterine Fibroids
- Registration Number
- NCT02748460
- Lead Sponsor
- PregLem SA
- Brief Summary
This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.
- Detailed Description
This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive, eligible, patients will be invited to enrol from approximately 100-150 European Union (EU) clinical practice sites in approximately 15 countries. Patients will be followed for an observation period of 60 months (5 years) from treatment start. Investigators are to manage and treat patients according to their standard medical practice.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1500
- Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and
- 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 is prescribed Esmya for pre-operative treatment
-
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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation Patients will be followed from baseline up to 60 months Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
- Secondary Outcome Measures
Name Time Method Assessment of Prescription pattern of Esmya in standard medical practice Patients will be followed from baseline up to 60 months Esmya use in patients
Trial Locations
- Locations (105)
Centre Hospitalier Regional De La Citadelle
🇧🇪Liege, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Clinique Universitaire de Mont Godinne
🇧🇪Yvoir, Belgium
Private Practice
🇵🇹Coimbra, Portugal
Josa Andras County Teaching Hospital
🇭🇺Nyiregyhaza, Hungary
Szent Anna Privat Surgery-Szent Anna Magae¡nrendela
🇭🇺Debrecen, Hungary
N. Lietuviete Private Practice
🇱🇻Riga, Latvia
RiGa 1st Hospital
🇱🇻Riga, Latvia
Medical Center Maxmeda
🇱🇹Vilnius, Lithuania
Genesys Fertility Center
🇷🇴Bucharest, Romania
Elena Doamna Obstetrics and Gynecology Clinical Hospital
🇷🇴Iasi, Romania
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Gyn-Porodnicka Klinika Fn Brno
🇨🇿Brno, Czechia
Dr Dvorak
🇨🇿Brno, Czechia
Gyn -Fsro
🇨🇿Králová, Czechia
Private Practice 2
🇨🇿Praha, Czechia
Uherskohradistska Nemocnice A.S
🇨🇿Uherske Hradiste, Czechia
Centre Hospitalier de Bethune
🇫🇷Béthune, France
Groupement Hospitalier Universitaire Sud CHU Bicetre
🇫🇷Le Kremlin-Bicêtre, France
Klinikum Bayreuth GmbH
🇩🇪Bayreuth, Germany
Private practice
🇩🇪Ribnitz-Damgarten, Germany
Gynakologische Praxis Klinik
🇩🇪Bonn, Germany
Hellweg gynakologie/DOCX
🇩🇪Geseke, Germany
Gemeinschaftspraxis der Frauenarztpraxis
🇩🇪Deggendorf, Germany
Frauenarztpraxis Gluckstadt
🇩🇪Gluckstadt, Germany
Praxisklinik Harburg
🇩🇪Hamburg, Germany
Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie
🇩🇪Hamburg, Germany
Ammerland Klinik GmbH
🇩🇪Westerstede, Germany
Medplus Krefeld
🇩🇪Krefeld, Germany
Endoskopie Und Endometriose-Zentrum Munchen
🇩🇪Muenchen, Germany
Azienda Usl Di Bologna
🇮🇹Bologna, Italy
ARS
🇱🇻Riga, Latvia
Latvian Maritime Medicine Centre
🇱🇻Riga, Latvia
Jsc Kardiolita
🇱🇹Vilnius, Lithuania
Radboud Universitair Medical Center
🇳🇱Nijmegen, Netherlands
Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw
🇵🇱Warszawa, Poland
Clinica Jardim das Amoreiras
🇵🇹Lisboa, Portugal
Centro hospitalar do Baixo vouga, EPE
🇵🇹Aveiro, Portugal
Centrul Medical Euromed
🇷🇴Bucuresti, Romania
Spitalul Clinic Dr. Ioan Cantacuzino
🇷🇴Bucuresti, Romania
Complejo Hospitalario Universitario A Coruna
🇪🇸A Coruna, Spain
ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)
🇪🇸Barcelona, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital General Hospitalet CSI
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari Quiron Dexeus Barcelona
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de Guadalajara (HUG)
🇪🇸Guadalajara, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Instituto Palacios, Salud y Medicina de la Mujer
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
🇬🇧Bath, United Kingdom
Hospital Quironsalud Toledo
🇪🇸Toledo, Spain
Danderyds Sjukhus AB
🇸🇪Stockholm, Sweden
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
University Hospital of North Durham
🇬🇧Durham, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, 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
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
Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, United Kingdom
Arrowe Park Hospital
🇬🇧Wirral, United Kingdom
Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche
🇮🇹Ancona, Italy
Policlinico S. Orsola Malpighi
🇮🇹Bologna, 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
University ""Magna Graecia"" Of Catanzaro
🇮🇹Catanzaro, Italy
Karolinska Institutet, Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust
🇬🇧Stockton-On-Tees, United Kingdom
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
G-Centrum Olomouc S.R.O.
🇨🇿Olomouc, Czechia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Gastroenheden Herlev-Gentofte
🇩🇰Herlev, Denmark
Hopital Bichat - Claude-Bernard
🇫🇷Paris Cedex, France
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
🇫🇷Tours Cedex 9, France
Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert
🇩🇪Berlin, Germany
Frauenarzt Bergedorf
🇩🇪Hamburg, Germany
Frauenarztpraxis
🇩🇪Kothen, Germany
Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪Gießen, Germany
Frauenarztpraxis Wandsbek
🇩🇪Hamburg, Germany
Csongrad Megyei Dr. Bugyi Istvan Korhaz
🇭🇺Szentes, Hungary
University of Bari Policlinico
🇮🇹Bari, Italy
A.O.Spedali Civili di Brescia
🇮🇹Brescia, Italy
PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie
🇩🇪Koln, Germany
Rethy Pal Hospital-Clinic Bekescsaba
🇭🇺Bekescsaba, Hungary
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
🇭🇺Szeged, Hungary
Robert Karoly Maganklinika
🇭🇺Budapest, Hungary
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain