Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
Premium
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.
1 other identifier
observational
1,527
16 countries
115
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2015
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2024
CompletedSeptember 2, 2025
August 1, 2025
8.3 years
April 19, 2016
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Patients will be followed from baseline up to 60 months
Secondary Outcomes (1)
Assessment of Prescription pattern of Esmya in standard medical practice
Patients will be followed from baseline up to 60 months
Study Arms (1)
Patients treated with Esmya
Any patient who was confirmed as receiving one dose of Esmya
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PregLem SAlead
Study Sites (115)
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
NyÃregyháza, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pablo Arriagada
PregLem SA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 22, 2016
Study Start
December 22, 2015
Primary Completion
April 11, 2024
Study Completion
April 11, 2024
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share