Clinical trial NCT01635452: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroids
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2012-07-09
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.

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


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
timeFrame: Patients will be followed from baseline up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: LKH Klagenfurt
city: St Pölten
country: Austria
facility: Private practice
city: Bordeaux
country: France
facility: CHU Pellegrin Gynécologie
city: Le Kremlin-Bicètre
country: France
facility: Hopital Bicetre
city: Marseille
country: France
facility: CHU La Conception
city: Nantes
country: France
facility: CHU Hôpital Mère-enfant
city: Paris
country: France
facility: Tenon CHU Paris Est
city: Reims
country: France
facility: CHUV Maison Blanche Institut
city: Rennes
country: France
facility: CHU Anne de Bretagne
city: Tours
country: France
facility: CHU Tours Gynécologie
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bayreuth
country: Germany
facility: Klinik am Hofgarten
city: Berlin
country: Germany
facility: Charite
city: Berlin
country: Germany
facility: Private practice
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn Friedensplatz
city: Bruchsal
country: Germany
facility: Private Practice
city: Diepholz
country: Germany
facility: Private Practice
city: Dorsten
country: Germany
facility: Private practive
city: Dortmund
country: Germany
facility: Private practice
city: Erlangen
country: Germany
facility: Frauenklinik, Universitätsklinikum Erlangen
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Freiburg
country: Germany
facility: Universitäts Frauenklinik
city: Geseke
country: Germany
facility: Gynäkologische Praxis
city: Hamburg-Harburg
country: Germany
facility: Gynaekologische Praxisklinik Harburger Ring
city: Hamburg
country: Germany
facility: Hormonzentrum Altonaerstrasse
city: Hoyerswerda
country: Germany
facility: Private practice
city: Ilsede
country: Germany
facility: Private practice
city: Krefeld
country: Germany
facility: Private practice
city: Köln
country: Germany
facility: Private practice
city: Mainz
country: Germany
facility: Gynäkologische Praxis
city: Munchen
country: Germany
facility: Endoskopie und Endometriose Zentrum
city: München
country: Germany
facility: Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde
city: Rodgau
country: Germany
facility: Private practice
city: Rotenburg
country: Germany
facility: Fachaerzte fuer Frauenheilkunde und Geburtshilfe
city: Völklingen
country: Germany
facility: Private practice
city: Budapest
country: Hungary
facility: Semmelweis University Faculty of Medicine
city: Pécs
country: Hungary
facility: University of Pécs Medical school
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi
city: Cagliari
country: Italy
facility: Universita di Cagliari
city: Catania
country: Italy
facility: Azienda Ospedaliera Garibaldi-Nesima
city: Cona
country: Italy
facility: Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: Università degli Studi di Firenze
city: Genova
country: Italy
facility: Clinica ospedale san martino e cliniche universitarie convenzionate di genova
city: Milano
country: Italy
facility: IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano
city: Roma
country: Italy
facility: La Sapienza University
city: Torino
country: Italy
facility: Ospedale Mauriziano "Umberto I"
city: Ketrzyn
country: Poland
facility: Private practice
city: Komorow
country: Poland
facility: Private practice
city: Lublin
country: Poland
facility: Private practice
city: Opole
country: Poland
facility: Private Practice
city: Plock
country: Poland
facility: Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa
city: Wroclaw
country: Poland
facility: Centrum Zdrowia mama i Ja
city: Zory
country: Poland
facility: Gabinet Ginekologiczny
city: Evora
country: Portugal
facility: Hospital do Espirito santo de Évora
city: Lisbon
country: Portugal
facility: Hospital da Luz-Lisboa
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta Militar Central
city: Cluj- Napoca
country: Romania
facility: OG Clinic II " Dominic Stanca "
city: Targu Mures
country: Romania
facility: Spitalul Clinic de Urgenta
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Madrid
country: Spain
facility: Hospital de la Zarzuela
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospitals NHS Trust
city: East Yorkshire
country: United Kingdom
facility: Hull and East Yorshire Eye Hospital
city: Epsom Surrey
country: United Kingdom
facility: Epsom & St Helier University Hospitals NHS Trust
city: Exeter
country: United Kingdom
facility: Royal devon and Exeter hospital
city: Hampshire
country: United Kingdom
facility: Royal Hampshire County Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Womens hospital
city: London
country: United Kingdom
facility: Barts and The London School of Medicine
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: PregLem SA
name: Jaime Oliver, MD
role: STUDY_DIRECTOR
References:
citation: Fernandez H, Descamps P, Koskas M, Lopes P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.