Clincosm LogoSign in Get a demo

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

Sponsor
PregLem SA (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02748460
Collaborator
(none)
1,500
Enrollment
115
Locations
84
Duration (Months)
13
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 Start Date :
    Dec 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patients treated with Esmya

    Any patient who was confirmed as receiving one dose of Esmya

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Assessment of Prescription pattern of Esmya in standard medical practice [Patients will be followed from baseline up to 60 months]

      Esmya use in patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cliniques Universitaires Saint-Luc Bruxelles Belgium
    2 Universitair Ziekenhuis Gent Gent Belgium
    3 Centre Hospitalier Regional De La Citadelle Liege Belgium
    4 Clinique Universitaire de Mont Godinne Yvoir Belgium
    5 Dr Dvorak Brno Czechia
    6 Gyn-Porodnicka Klinika Fn Brno Brno Czechia
    7 Gyn -Fsro Králová Czechia
    8 G-Centrum Olomouc S.R.O. Olomouc Czechia
    9 Private Practice 2 Praha Czechia
    10 Private Practice Praha Czechia
    11 Uherskohradistska Nemocnice A.S Uherske Hradiste Czechia
    12 Aarhus University Hospital Aarhus Denmark
    13 Gastroenheden Herlev-Gentofte Herlev Denmark
    14 Centre Hospitalier Universitaire d'Angers Angers France
    15 Centre Hospitalier de Bethune Béthune France
    16 Groupement Hospitalier Universitaire Sud CHU Bicetre Le Kremlin-Bicêtre France
    17 Hopital Bichat - Claude-Bernard Paris Cedex France
    18 Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau Tours Cedex 9 France
    19 Private practice Aachen Germany
    20 Klinikum Bayreuth GmbH Bayreuth Germany
    21 Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin Berlin Germany
    22 Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert Berlin Germany
    23 Gynakologische Praxis Klinik Bonn Germany
    24 Gemeinschaftspraxis der Frauenarztpraxis Deggendorf Germany
    25 Private Practice Dortmund Germany
    26 Frauenarztpraxis Frankfurt Am Main Germany
    27 Private Practice Frankfurt Germany
    28 Hellweg gynakologie/DOCX Geseke Germany
    29 Universitaetsklinikum Giessen und Marburg GmbH Gießen Germany
    30 Frauenarztpraxis Gluckstadt Gluckstadt Germany
    31 Frauenarzt Bergedorf Hamburg Germany
    32 Frauenarztpraxis Wandsbek Hamburg Germany
    33 Praxisklinik Harburg Hamburg Germany
    34 Private Practice Hamburg Germany
    35 Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie Hamburg Germany
    36 Private practice Ilsede Germany
    37 PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie Koln Germany
    38 Frauenarztpraxis Kothen Germany
    39 Medplus Krefeld Krefeld Germany
    40 Endoskopie Und Endometriose-Zentrum Munchen Muenchen Germany
    41 Private Practice Plocking Germany
    42 Private practice Ribnitz-Damgarten Germany
    43 Private Practice Stolberg Germany
    44 Ammerland Klinik GmbH Westerstede Germany
    45 Rethy Pal Hospital-Clinic Bekescsaba Bekescsaba Hungary
    46 Robert Karoly Maganklinika Budapest Hungary
    47 Szent Anna Privat Surgery-Szent Anna Magae¡nrendela Debrecen Hungary
    48 Josa Andras County Teaching Hospital Nyiregyhaza Hungary
    49 Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika Szeged Hungary
    50 Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes Hungary
    51 Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche Ancona Italy
    52 University of Bari Policlinico Bari Italy
    53 Azienda Usl Di Bologna Bologna Italy
    54 Policlinico S. Orsola Malpighi Bologna Italy
    55 A.O.Spedali Civili di Brescia Brescia Italy
    56 University ""Magna Graecia"" Of Catanzaro Catanzaro Italy
    57 Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo Pavia Italy
    58 Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte Siena Italy
    59 University of Torino, S. Anna Hospital- City of Health and Science Torino Italy
    60 ARS Riga Latvia
    61 Latvian Maritime Medicine Centre Riga Latvia
    62 N. Lietuviete Private Practice Riga Latvia
    63 Private Practice Riga Latvia
    64 RiGa 1st Hospital Riga Latvia
    65 Jsc Kardiolita Vilnius Lithuania
    66 Medical Center Maxmeda Vilnius Lithuania
    67 Radboud Universitair Medical Center Nijmegen Netherlands
    68 Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw Warszawa Poland
    69 Centro hospitalar do Baixo vouga, EPE Aveiro Portugal
    70 Private Practice Coimbra Portugal
    71 Clinica Jardim das Amoreiras Lisboa Portugal
    72 Genesys Fertility Center Bucharest Romania
    73 Centrul Medical Euromed Bucuresti Romania
    74 Spitalul Clinic Dr. Ioan Cantacuzino Bucuresti Romania
    75 Elena Doamna Obstetrics and Gynecology Clinical Hospital Iasi Romania
    76 Complejo Hospitalario Universitario A Coruna A Coruna Spain
    77 Hospital Universitario de Cruces Barakaldo Spain
    78 ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut) Barcelona Spain
    79 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    80 Hospital General Hospitalet CSI Barcelona Spain
    81 Hospital Universitari Quiron Dexeus Barcelona Barcelona Spain
    82 Hospital Universitari Vall d'Hebron Barcelona Spain
    83 Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona Barcelona Spain
    84 Hospital Universitario de Guadalajara (HUG) Guadalajara Spain
    85 Hospital Clinico San Carlos Madrid Spain
    86 Hospital General Universitario Gregorio Maranon Madrid Spain
    87 Hospital Universitario 12 de Octubre Madrid Spain
    88 Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
    89 Hospital Universitario La Paz Madrid Spain
    90 Hospital Universitario Ramon y Cajal Madrid Spain
    91 Instituto Palacios, Salud y Medicina de la Mujer Madrid Spain
    92 Hospital Universitario Puerta de Hierro Majadahonda Spain
    93 Hospital Regional Universitario Carlos Haya Malaga Spain
    94 Hospital Quironsalud Toledo Toledo Spain
    95 Hospital Universitario y Politecnico La Fe Valencia Spain
    96 Danderyds Sjukhus AB Stockholm Sweden
    97 Karolinska Institutet, Karolinska University Hospital Huddinge Stockholm Sweden
    98 Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust Bath United Kingdom
    99 Royal Bolton Hospital Bolton United Kingdom
    100 University Hospital of North Durham Durham United Kingdom
    101 London North West Healthcare NHS Trust Harrow United Kingdom
    102 Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust Hull United Kingdom
    103 Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital Huntingdon United Kingdom
    104 Leicester General Hospital Leicester United Kingdom
    105 North Middlesex University Hospital London United Kingdom
    106 Queen Charlotte's & Chelsea Hospital London United Kingdom
    107 Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust Manchester United Kingdom
    108 Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne United Kingdom
    109 Norfolk and Norwich University Hospital Norwich United Kingdom
    110 Rosemere Cancer Centre - Royal Preston Hospital Preston United Kingdom
    111 Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing Sheffield United Kingdom
    112 University Hospital Southampton NHS Foundation Trust Southampton United Kingdom
    113 University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust Stockton-On-Tees United Kingdom
    114 Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust Stoke-on-Trent United Kingdom
    115 Arrowe Park Hospital Wirral United Kingdom

    Sponsors and Collaborators

    • PregLem SA

    Investigators

    • Study Director: Pablo Arriagada, PregLem SA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PregLem SA
    ClinicalTrials.gov Identifier:
    NCT02748460
    Other Study ID Numbers:
    • PGL14-001 (PREMIUM)
    First Posted:
    Apr 22, 2016
    Last Update Posted:
    Oct 16, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Leiomyoma

    Study Results

    No Results Posted as of Oct 16, 2019