Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

Uterine Fibroids Clinical Trial

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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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02748460
• Other study ID #: PGL14-001 (PREMIUM)
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: December 2022

Study information

• Verified date: October 2019
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Centre Hospitalier Regional De La Citadelle	Liege
Belgium	Clinique Universitaire de Mont Godinne	Yvoir
Czechia	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	Praha
Czechia	Private Practice 2	Praha
Czechia	Uherskohradistska Nemocnice A.S	Uherske Hradiste
Denmark	Aarhus University Hospital	Aarhus
Denmark	Gastroenheden Herlev-Gentofte	Herlev
France	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 Cedex
France	Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau	Tours Cedex 9
Germany	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	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	Gluckstadt
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	PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie	Koln
Germany	Frauenarztpraxis	Kothen
Germany	Medplus Krefeld	Krefeld
Germany	Endoskopie Und Endometriose-Zentrum Munchen	Muenchen
Germany	Private Practice	Plocking
Germany	Private practice	Ribnitz-Damgarten
Germany	Private Practice	Stolberg
Germany	Ammerland Klinik GmbH	Westerstede
Hungary	Rethy Pal Hospital-Clinic Bekescsaba	Bekescsaba
Hungary	Robert Karoly Maganklinika	Budapest
Hungary	Szent Anna Privat Surgery-Szent Anna Magae¡nrendela	Debrecen
Hungary	Josa Andras County Teaching Hospital	Nyiregyhaza
Hungary	Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika	Szeged
Hungary	Csongrad Megyei Dr. Bugyi Istvan Korhaz	Szentes
Italy	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
Latvia	ARS	Riga
Latvia	Latvian Maritime Medicine Centre	Riga
Latvia	N. Lietuviete Private Practice	Riga
Latvia	Private Practice	Riga
Latvia	RiGa 1st Hospital	Riga
Lithuania	Jsc Kardiolita	Vilnius
Lithuania	Medical Center Maxmeda	Vilnius
Netherlands	Radboud Universitair Medical Center	Nijmegen
Poland	Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw	Warszawa
Portugal	Centro hospitalar do Baixo vouga, EPE	Aveiro
Portugal	Private Practice	Coimbra
Portugal	Clinica Jardim das Amoreiras	Lisboa
Romania	Genesys Fertility Center	Bucharest
Romania	Centrul Medical Euromed	Bucuresti
Romania	Spitalul Clinic Dr. Ioan Cantacuzino	Bucuresti
Romania	Elena Doamna Obstetrics and Gynecology Clinical Hospital	Iasi
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
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	Malaga
Spain	Hospital Quironsalud Toledo	Toledo
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Sweden	Danderyds Sjukhus AB	Stockholm
Sweden	Karolinska Institutet, Karolinska University Hospital Huddinge	Stockholm
United Kingdom	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	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	Arrowe Park Hospital	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Netherlands,  Poland,  Portugal,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of Prescription pattern of Esmya in standard medical practice	Esmya use in patients	Patients will be followed from baseline up to 60 months