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)

January 26, 2015 updated by: PregLem SA

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Klagenfurt, Austria
        • LKH Klagenfurt
      • St Pölten, Austria
        • Private Practice
  • France
      • Bordeaux, France
        • CHU Pellegrin Gynécologie
      • Le Kremlin-Bicètre, France
        • Hôpital Bicêtre
      • Marseille, France
        • CHU la Conception
      • Nantes, France
        • CHU Hôpital Mère-enfant
      • Paris, France
        • Tenon CHU Paris Est
      • Reims, France
        • CHUV Maison Blanche Institut
      • Rennes, France
        • CHU Anne de Bretagne
      • Tours, France
        • CHU Tours Gynécologie
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Bayreuth, Germany
        • Klinik am Hofgarten
      • Berlin, Germany
        • Charité
      • Berlin, Germany
        • Private Practice
      • Bonn, Germany
        • Medizinisches Zentrum Bonn Friedensplatz
      • Bruchsal, Germany
        • Private Practice
      • Diepholz, Germany
        • Private Practice
      • Dorsten, Germany
        • Private practive
      • Dortmund, Germany
        • Private Practice
      • Erlangen, Germany
        • Frauenklinik, Universitatsklinikum Erlangen
      • Esslingen, Germany
        • Klinikum Esslingen
      • Freiburg, Germany
        • Universitäts Frauenklinik
      • Geseke, Germany
        • Gynäkologische Praxis
      • Hamburg, Germany
        • Hormonzentrum Altonaerstrasse
      • Hamburg-Harburg, Germany
        • Gynaekologische Praxisklinik Harburger Ring
      • Hoyerswerda, Germany
        • Private Practice
      • Ilsede, Germany
        • Private Practice
      • Krefeld, Germany
        • Private Practice
      • Köln, Germany
        • Private Practice
      • Mainz, Germany
        • Gynäkologische Praxis
      • Munchen, Germany
        • Endoskopie und Endometriose Zentrum
      • München, Germany
        • Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde
      • Rodgau, Germany
        • Private Practice
      • Rotenburg, Germany
        • Fachaerzte fuer Frauenheilkunde und Geburtshilfe
      • Völklingen, Germany
        • Private Practice
  • Hungary
      • Budapest, Hungary
        • Semmelweis University Faculty of Medicine
      • Pécs, Hungary
        • University of Pecs Medical School
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi
      • Cagliari, Italy
        • Università di Cagliari
      • Catania, Italy
        • Azienda Ospedaliera Garibaldi-Nesima
      • Cona, Italy
        • Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna
      • Firenze, Italy
        • Universita Degli Studi Di Firenze
      • Genova, Italy
        • Clinica ospedale san martino e cliniche universitarie convenzionate di genova
      • Milano, Italy
        • IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano
      • Roma, Italy
        • La Sapienza University
      • Torino, Italy
        • Ospedale Mauriziano "Umberto I"
  • Poland
      • Ketrzyn, Poland
        • Private Practice
      • Komorow, Poland
        • Private Practice
      • Lublin, Poland
        • Private Practice
      • Opole, Poland
        • Private Practice
      • Plock, Poland
        • Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa
      • Wroclaw, Poland
        • Centrum Zdrowia mama i Ja
      • Zory, Poland
        • Gabinet Ginekologiczny
  • Portugal
      • Evora, Portugal
        • Hospital do Espírito Santo de Évora
      • Lisbon, Portugal
        • Hospital da Luz-Lisboa
  • Romania
      • Bucharest, Romania
        • Spitalul Clinic de Urgenta Militar Central
      • Cluj- Napoca, Romania
        • OG Clinic II " Dominic Stanca "
      • Targu Mures, Romania
        • Spitalul clinic de urgenta
  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Sant Pau
      • Madrid, Spain
        • Hospital de la Zarzuela
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Toledo, Spain
        • Hospital Virgen de la Salud
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Carlisle, United Kingdom
        • North Cumbria University Hospitals NHS Trust
      • East Yorkshire, United Kingdom
        • Hull and East Yorshire Eye Hospital
      • Epsom Surrey, United Kingdom
        • Epsom & St Helier University Hospitals NHS Trust
      • Exeter, United Kingdom
        • Royal Devon and Exeter Hospital
      • Hampshire, United Kingdom
        • Royal Hampshire County Hospital
      • Leicester, United Kingdom
        • University Hospitals Of Leicester Nhs Trust
      • Liverpool, United Kingdom
        • Liverpool Womens Hospital
      • London, United Kingdom
        • Barts and the London School of Medicine
      • London, United Kingdom
        • King's College Hospital NHS Foundation
      • Nottingham, United Kingdom
        • Nottingham University Hospital NHS Trust
      • Southampton, United Kingdom
        • Southampton University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients treated with Esmya

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PregLem SA

Investigators

  • Study Director: Jaime Oliver, MD, PregLem SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGL10-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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