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.

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Fibroids

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients treated with Esmya; Any patient who was confirmed as receiving one dose of Esmya

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Prescription pattern of Esmya in standard medical practice	Esmya use in patients	Patients will be followed from baseline up to 60 months

Collaborators and Investigators

• Sponsor: PregLem SA
• Investigators: Study Director: Pablo Arriagada, PregLem SA

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: PGL14-001 (PREMIUM)