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
PREMYA
1 other identifier
observational
1,500
10 countries
75
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 27, 2015
January 1, 2015
1.9 years
June 26, 2012
January 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients treated with Esmya
Eligibility Criteria
The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
You may qualify if:
- \- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PregLem SAlead
Study Sites (75)
LKH Klagenfurt
Klagenfurt, Austria
Private practice
Sankt Pölten, Austria
CHU Pellegrin Gynécologie
Bordeaux, France
Hopital Bicetre
Le Kremlin-Bicètre, France
CHU La Conception
Marseille, France
CHU Hôpital Mère-enfant
Nantes, France
Tenon CHU Paris Est
Paris, France
CHUV Maison Blanche Institut
Reims, France
CHU Anne de Bretagne
Rennes, France
CHU Tours Gynécologie
Tours, France
Universitätsklinikum Aachen
Aachen, Germany
Klinik am Hofgarten
Bayreuth, Germany
Charite
Berlin, Germany
Private practice
Berlin, Germany
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany
Private Practice
Bruchsal, Germany
Private practice
Cologne, Germany
Private Practice
Diepholz, Germany
Private practive
Dorsten, Germany
Private practice
Dortmund, Germany
Frauenklinik, Universitätsklinikum Erlangen
Erlangen, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Universitäts Frauenklinik
Freiburg im Breisgau, Germany
Gynäkologische Praxis
Geseke, Germany
Hormonzentrum Altonaerstrasse
Hamburg, Germany
Gynaekologische Praxisklinik Harburger Ring
Harburg, Germany
Private practice
Hoyerswerda, Germany
Private practice
Ilsede, Germany
Private practice
Krefeld, Germany
Gynäkologische Praxis
Mainz, Germany
Endoskopie und Endometriose Zentrum
München, Germany
Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde
München, Germany
Private practice
Rodgau, Germany
Fachaerzte fuer Frauenheilkunde und Geburtshilfe
Rotenburg (Wümme), Germany
Private practice
Völklingen, Germany
Semmelweis University Faculty of Medicine
Budapest, Hungary
University of Pécs Medical school
Pécs, Hungary
Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi
Bologna, Italy
Universita di Cagliari
Cagliari, Italy
Azienda Ospedaliera Garibaldi-Nesima
Catania, Italy
Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna
Cona, Italy
Università degli Studi di Firenze
Florence, Italy
Clinica ospedale san martino e cliniche universitarie convenzionate di genova
Genova, Italy
IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano
Milan, Italy
La Sapienza University
Roma, Italy
Ospedale Mauriziano "Umberto I"
Torino, Italy
Private practice
Kętrzyn, Poland
Private practice
Komorów, Poland
Private practice
Lublin, Poland
Private Practice
Opole, Poland
Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa
Płock, Poland
Centrum Zdrowia mama i Ja
Wroclaw, Poland
Gabinet Ginekologiczny
Żory, Poland
Hospital do Espirito santo de Évora
Evora, Portugal
Hospital da Luz-Lisboa
Lisbon, Portugal
Spitalul Clinic de Urgenta Militar Central
Bucharest, Romania
OG Clinic II " Dominic Stanca "
Cluj-Napoca, Romania
Spitalul Clinic de Urgenta
Târgu Mureş, Romania
Hospital del Mar
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital de la Zarzuela
Madrid, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Virgen de la Salud
Toledo, Spain
Bradford Royal Infirmary
Bradford, United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, United Kingdom
Hull and East Yorshire Eye Hospital
East Yorkshire, United Kingdom
Epsom & St Helier University Hospitals NHS Trust
Epsom Surrey, United Kingdom
Royal devon and Exeter hospital
Exeter, 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
Nottingham University Hospital NHS trust
Nottingham, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 28676450DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaime Oliver, MD
PregLem SA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2012
First Posted
July 9, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2014
Study Completion
March 1, 2016
Last Updated
January 27, 2015
Record last verified: 2015-01