Clinical trial NCT02748460: Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
Official title: Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroids
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population will include women with moderate to severe symptoms of uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and subjects who were previously exposed to UPA 5 or 10 mg in Long Term Phase III clinical trials PGL09-027 (PEARL III extension; including patients of PGL11-024 (PEARL extension 2)), or PGL11-006 (PEARL IV).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
timeFrame: Patients will be followed from baseline up to 60 months
Secondary outcomes:
measure: Assessment of Prescription pattern of Esmya in standard medical practice
timeFrame: Patients will be followed from baseline up to 60 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: Centre Hospitalier Regional De La Citadelle
city: Yvoir
country: Belgium
facility: Clinique Universitaire de Mont Godinne
city: Brno
country: Czechia
facility: Dr Dvorak
city: Brno
country: Czechia
facility: Gyn-Porodnicka Klinika Fn Brno
city: Králová
country: Czechia
facility: Gyn -Fsro
city: Olomouc
country: Czechia
facility: G-Centrum Olomouc S.R.O.
city: Praha
country: Czechia
facility: Private Practice 2
city: Praha
country: Czechia
facility: Private Practice
city: Uherske Hradiste
country: Czechia
facility: Uherskohradistska Nemocnice A.S
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Herlev
country: Denmark
facility: Gastroenheden Herlev-Gentofte
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Béthune
country: France
facility: Centre Hospitalier de Bethune
city: Le Kremlin-Bicêtre
country: France
facility: Groupement Hospitalier Universitaire Sud CHU Bicetre
city: Paris Cedex
country: France
facility: Hopital Bichat - Claude-Bernard
city: Tours Cedex 9
country: France
facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
city: Aachen
country: Germany
facility: Private practice
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
city: Berlin
country: Germany
facility: Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert
city: Bonn
country: Germany
facility: Gynakologische Praxis Klinik
city: Deggendorf
country: Germany
facility: Gemeinschaftspraxis der Frauenarztpraxis
city: Dortmund
country: Germany
facility: Private Practice
city: Frankfurt Am Main
country: Germany
facility: Frauenarztpraxis
city: Frankfurt
country: Germany
facility: Private Practice
city: Geseke
country: Germany
facility: Hellweg gynakologie/DOCX
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Gluckstadt
country: Germany
facility: Frauenarztpraxis Gluckstadt
city: Hamburg
country: Germany
facility: Frauenarzt Bergedorf
city: Hamburg
country: Germany
facility: Frauenarztpraxis Wandsbek
city: Hamburg
country: Germany
facility: Praxisklinik Harburg
city: Hamburg
country: Germany
facility: Private Practice
city: Hamburg
country: Germany
facility: Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie
city: Ilsede
country: Germany
facility: Private practice
city: Koln
country: Germany
facility: PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie
city: Kothen
country: Germany
facility: Frauenarztpraxis
city: Krefeld
country: Germany
facility: Medplus Krefeld
city: Muenchen
country: Germany
facility: Endoskopie Und Endometriose-Zentrum Munchen
city: Plocking
country: Germany
facility: Private Practice
city: Ribnitz-Damgarten
country: Germany
facility: Private practice
city: Stolberg
country: Germany
facility: Private Practice
city: Westerstede
country: Germany
facility: Ammerland Klinik GmbH
city: Bekescsaba
country: Hungary
facility: Rethy Pal Hospital-Clinic Bekescsaba
city: Budapest
country: Hungary
facility: Robert Karoly Maganklinika
city: Debrecen
country: Hungary
facility: Szent Anna Privat Surgery-Szent Anna Magae¡nrendela
city: Nyiregyhaza
country: Hungary
facility: Josa Andras County Teaching Hospital
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Ancona
country: Italy
facility: Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche
city: Bari
country: Italy
facility: University of Bari Policlinico
city: Bologna
country: Italy
facility: Azienda Usl Di Bologna
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: A.O.Spedali Civili di Brescia
city: Catanzaro
country: Italy
facility: University ""Magna Graecia"" Of Catanzaro
city: Pavia
country: Italy
facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte
city: Torino
country: Italy
facility: University of Torino, S. Anna Hospital- City of Health and Science
city: Riga
country: Latvia
facility: ARS
city: Riga
country: Latvia
facility: Latvian Maritime Medicine Centre
city: Riga
country: Latvia
facility: N. Lietuviete Private Practice
city: Riga
country: Latvia
facility: Private Practice
city: Riga
country: Latvia
facility: RiGa 1st Hospital
city: Vilnius
country: Lithuania
facility: Jsc Kardiolita
city: Vilnius
country: Lithuania
facility: Medical Center Maxmeda
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medical Center
city: Warszawa
country: Poland
facility: Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw
city: Aveiro
country: Portugal
facility: Centro hospitalar do Baixo vouga, EPE
city: Coimbra
country: Portugal
facility: Private Practice
city: Lisboa
country: Portugal
facility: Clinica Jardim das Amoreiras
city: Bucharest
country: Romania
facility: Genesys Fertility Center
city: Bucuresti
country: Romania
facility: Centrul Medical Euromed
city: Bucuresti
country: Romania
facility: Spitalul Clinic Dr. Ioan Cantacuzino
city: Iasi
country: Romania
facility: Elena Doamna Obstetrics and Gynecology Clinical Hospital
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital General Hospitalet CSI
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara (HUG)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Instituto Palacios, Salud y Medicina de la Mujer
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Toledo
country: Spain
facility: Hospital Quironsalud Toledo
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus AB
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital Huddinge
city: Bath
country: United Kingdom
facility: Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
city: Harrow
country: United Kingdom
facility: London North West Healthcare NHS Trust
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: London
country: United Kingdom
facility: Queen Charlotte's & Chelsea Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre - Royal Preston Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Stockton-On-Tees
country: United Kingdom
facility: University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital
Study officials:
affiliation: PregLem SA
name: Pablo Arriagada
role: STUDY_DIRECTOR
References: