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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01635452
Other study ID # PGL10-014
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A