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

Uterine Fibroids Clinical Trial

— PREMYA  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01635452
• Other study ID #: PGL10-014
• Status: Active, not recruiting
• Phase: N/A
• First received: June 26, 2012
• Last updated: January 26, 2015
• Start date: May 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2015
• Source: PregLem SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionSpain: Ethics CommitteeFrance: Institutional Ethical CommitteeItaly: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: March 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Locations

Country	Name	City	State
Austria	LKH Klagenfurt	Klagenfurt
Austria	Private practice	St Pölten
France	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
Germany	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	Diepholz
Germany	Private practive	Dorsten
Germany	Private practice	Dortmund
Germany	Frauenklinik, Universitätsklinikum Erlangen	Erlangen
Germany	Klinikum Esslingen	Esslingen
Germany	Universitäts Frauenklinik	Freiburg
Germany	Gynäkologische Praxis	Geseke
Germany	Hormonzentrum Altonaerstrasse	Hamburg
Germany	Gynaekologische Praxisklinik Harburger Ring	Hamburg-Harburg
Germany	Private practice	Hoyerswerda
Germany	Private practice	Ilsede
Germany	Private practice	Köln
Germany	Private practice	Krefeld
Germany	Gynäkologische Praxis	Mainz
Germany	Endoskopie und Endometriose Zentrum	Munchen
Germany	Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde	München
Germany	Private practice	Rodgau
Germany	Fachaerzte fuer Frauenheilkunde und Geburtshilfe	Rotenburg
Germany	Private practice	Völklingen
Hungary	Semmelweis University Faculty of Medicine	Budapest
Hungary	University of Pécs Medical school	Pécs
Italy	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	Firenze
Italy	Clinica ospedale san martino e cliniche universitarie convenzionate di genova	Genova
Italy	IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano	Milano
Italy	La Sapienza University	Roma
Italy	Ospedale Mauriziano "Umberto I"	Torino
Poland	Private practice	Ketrzyn
Poland	Private practice	Komorow
Poland	Private practice	Lublin
Poland	Private Practice	Opole
Poland	Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa	Plock
Poland	Centrum Zdrowia mama i Ja	Wroclaw
Poland	Gabinet Ginekologiczny	Zory
Portugal	Hospital do Espirito santo de Évora	Evora
Portugal	Hospital da Luz-Lisboa	Lisbon
Romania	Spitalul Clinic de Urgenta Militar Central	Bucharest
Romania	OG Clinic II " Dominic Stanca "	Cluj- Napoca
Romania	Spitalul Clinic de Urgenta	Targu Mures
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital de la Zarzuela	Madrid
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital Virgen de la Salud	Toledo
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
PregLem SA

Countries where clinical trial is conducted

Austria,  France,  Germany,  Hungary,  Italy,  Poland,  Portugal,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes