A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids

• Conditions: Uterine Fibroids

• Registration Number: NCT01635452
• Lead Sponsor: PregLem SA

Brief Summary

This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.

The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-09
• Primary Completion: 2014-04
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.

Exclusion Criteria

• Patient is pregnant or plans to become pregnant in the next 3 months,
• Patient is breastfeeding,
• Patient has genital bleeding of unknown etiology or not due to uterine fibroids,
• Patient has been diagnosed with uterine, cervical, ovarian or breast cancer,
• Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment,
• Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.	Patients will be followed from baseline up to 15 months

Trial Locations

Locations (61)

Private practice; 🇵🇱 Lublin, Poland

Gabinet Ginekologiczny; 🇵🇱 Zory, Poland

Hospital do Espirito santo de Évora; 🇵🇹 Evora, Portugal

Hospital da Luz-Lisboa; 🇵🇹 Lisbon, Portugal

Spitalul Clinic de Urgenta; 🇷🇴 Targu Mures, Romania

Tenon CHU Paris Est; 🇫🇷 Paris, France

Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde; 🇩🇪 München, Germany

Royal devon and Exeter hospital; 🇬🇧 Exeter, United Kingdom

Southampton University Hospital; 🇬🇧 Southampton, United Kingdom

Nottingham University Hospital NHS trust; 🇬🇧 Nottingham, United Kingdom

Universitäts Frauenklinik; 🇩🇪 Freiburg, Germany

CHU Anne de Bretagne; 🇫🇷 Rennes, France

CHU Pellegrin Gynécologie; 🇫🇷 Bordeaux, France

Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa; 🇵🇱 Plock, Poland

Centrum Zdrowia mama i Ja; 🇵🇱 Wroclaw, Poland

Clinica ospedale san martino e cliniche universitarie convenzionate di genova; 🇮🇹 Genova, Italy

IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano; 🇮🇹 Milano, Italy

Ospedale Mauriziano "Umberto I"; 🇮🇹 Torino, Italy

Hull and East Yorshire Eye Hospital; 🇬🇧 East Yorkshire, United Kingdom

La Sapienza University; 🇮🇹 Roma, Italy

Endoskopie und Endometriose Zentrum; 🇩🇪 Munchen, Germany

University of Pécs Medical school; 🇭🇺 Pécs, Hungary

Hospital de la Zarzuela; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Private Practice; 🇵🇱 Opole, Poland

CHU Tours Gynécologie; 🇫🇷 Tours, France

Gynäkologische Praxis; 🇩🇪 Mainz, Germany

Gynaekologische Praxisklinik Harburger Ring; 🇩🇪 Hamburg-Harburg, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Klinik am Hofgarten; 🇩🇪 Bayreuth, Germany

Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi; 🇮🇹 Bologna, Italy

Universita di Cagliari; 🇮🇹 Cagliari, Italy

Azienda Ospedaliera Garibaldi-Nesima; 🇮🇹 Catania, Italy

Università degli Studi di Firenze; 🇮🇹 Firenze, Italy

Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna; 🇮🇹 Cona, Italy

Hormonzentrum Altonaerstrasse; 🇩🇪 Hamburg, Germany

Semmelweis University Faculty of Medicine; 🇭🇺 Budapest, Hungary

Fachaerzte fuer Frauenheilkunde und Geburtshilfe; 🇩🇪 Rotenburg, Germany

Klinikum Esslingen; 🇩🇪 Esslingen, Germany

LKH Klagenfurt; 🇦🇹 Klagenfurt, Austria

CHU La Conception; 🇫🇷 Marseille, France

Hopital Bicetre; 🇫🇷 Le Kremlin-Bicètre, France

CHU Hôpital Mère-enfant; 🇫🇷 Nantes, France

CHUV Maison Blanche Institut; 🇫🇷 Reims, France

Charite; 🇩🇪 Berlin, Germany

Frauenklinik, Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Spitalul Clinic de Urgenta Militar Central; 🇷🇴 Bucharest, Romania

OG Clinic II " Dominic Stanca "; 🇷🇴 Cluj- Napoca, Romania

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

North Cumbria University Hospitals NHS Trust; 🇬🇧 Carlisle, United Kingdom

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Epsom & St Helier University Hospitals NHS Trust; 🇬🇧 Epsom Surrey, United Kingdom

Royal Hampshire County Hospital; 🇬🇧 Hampshire, United Kingdom

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom

Liverpool Womens hospital; 🇬🇧 Liverpool, United Kingdom

Barts and The London School of Medicine; 🇬🇧 London, United Kingdom

King's College Hospital NHS Foundation; 🇬🇧 London, United Kingdom

Private practive; 🇩🇪 Dorsten, Germany

Medizinisches Zentrum Bonn Friedensplatz; 🇩🇪 Bonn, Germany

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain