Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting (Premium)

August 25, 2025 updated by: PregLem SA

Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive, eligible, patients will be invited to enrol from approximately 100-150 European Union (EU) clinical practice sites in approximately 15 countries. Patients will be followed for an observation period of 60 months (5 years) from treatment start. Investigators are to manage and treat patients according to their standard medical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1527

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

  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
      • Liège, Belgium
        • Centre Hospitalier Régional de la Citadelle
      • Yvoir, Belgium
        • Clinique Universitaire de Mont Godinne
  • Czechia
      • Brno, Czechia
        • Dr Dvorak
      • Brno, Czechia
        • Gyn-Porodnicka Klinika Fn Brno
      • Králová, Czechia
        • Gyn -Fsro
      • Olomouc, Czechia
        • G-Centrum Olomouc S.R.O.
      • Prague, Czechia
        • Private Practice 2
      • Prague, Czechia
        • Private Practice
      • Uherské Hradiště, Czechia
        • Uherskohradistska Nemocnice A.S
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Herlev, Denmark
        • Gastroenheden Herlev-Gentofte
  • France
      • Angers, France
        • Centre Hospitalier Universitaire d'Angers
      • Béthune, France
        • Centre Hospitalier de Béthune
      • Le Kremlin-Bicêtre, France
        • Groupement Hospitalier Universitaire Sud CHU Bicetre
      • Paris, France
        • Hôpital Bichat - Claude-Bernard
      • Tours, France
        • Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
  • Germany
      • Aachen, Germany
        • Private Practice
      • Bayreuth, Germany
        • Klinikum Bayreuth GmbH
      • Berlin, Germany
        • Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin
      • Berlin, Germany
        • Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert
      • Bonn, Germany
        • Gynakologische Praxis Klinik
      • Cologne, Germany
        • PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie
      • Deggendorf, Germany
        • Gemeinschaftspraxis der Frauenarztpraxis
      • Dortmund, Germany
        • Private Practice
      • Frankfurt, Germany
        • Private Practice
      • Frankfurt am Main, Germany
        • Frauenarztpraxis
      • Geseke, Germany
        • Hellweg gynakologie/DOCX
      • Giessen, Germany
        • Universitaetsklinikum Giessen und Marburg GmbH
      • Glückstadt, Germany
        • Frauenarztpraxis Gluckstadt
      • Hamburg, Germany
        • Frauenarzt Bergedorf
      • Hamburg, Germany
        • Frauenarztpraxis Wandsbek
      • Hamburg, Germany
        • Praxisklinik Harburg
      • Hamburg, Germany
        • Private Practice
      • Hamburg, Germany
        • Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie
      • Ilsede, Germany
        • Private Practice
      • Krefeld, Germany
        • Medplus Krefeld
      • Köthen, Germany
        • Frauenarztpraxis
      • München, Germany
        • Endoskopie Und Endometriose-Zentrum Munchen
      • Plöcking, Germany
        • Private Practice
      • Ribnitz-Damgarten, Germany
        • Private Practice
      • Stolberg, Germany
        • Private Practice
      • Westerstede, Germany
        • Ammerland Klinik GmbH
  • Hungary
      • Budapest, Hungary
        • Robert Karoly Maganklinika
      • Békéscsaba, Hungary
        • Rethy Pal Hospital-Clinic Bekescsaba
      • Debrecen, Hungary
        • Szent Anna Privat Surgery-Szent Anna Magae¡nrendela
      • Nyíregyháza, Hungary
        • Josa Andras County Teaching Hospital
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
      • Szentes, Hungary
        • Csongrád Megyei Dr. Bugyi István Kórház
  • Italy
      • Ancona, Italy
        • Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche
      • Bari, Italy
        • University of Bari Policlinico
      • Bologna, Italy
        • Policlinico S. Orsola Malpighi
      • Bologna, Italy
        • Azienda USL di Bologna
      • Brescia, Italy
        • A.O.Spedali Civili di Brescia
      • Catanzaro, Italy
        • University ""Magna Graecia"" Of Catanzaro
      • Pavia, Italy
        • Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte
      • Torino, Italy
        • University of Torino, S. Anna Hospital- City of Health and Science
  • Latvia
      • Riga, Latvia
        • Latvian Maritime Medicine Centre
      • Riga, Latvia
        • ARS
      • Riga, Latvia
        • N. Lietuviete Private Practice
      • Riga, Latvia
        • Private Practice
      • Riga, Latvia
        • Riga 1st Hospital
  • Lithuania
      • Vilnius, Lithuania
        • Jsc Kardiolita
      • Vilnius, Lithuania
        • Medical Center Maxmeda
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud Universitair Medical Center
  • Poland
      • Warsaw, Poland
        • Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw
  • Portugal
      • Aveiro, Portugal
        • Centro hospitalar do Baixo vouga, EPE
      • Coimbra, Portugal
        • Private Practice
      • Lisbon, Portugal
        • Clinica Jardim das Amoreiras
  • Romania
      • Bucharest, Romania
        • Genesys Fertility Center
      • Bucharest, Romania
        • Centrul Medical Euromed
      • Bucharest, Romania
        • Spitalul Clinic Dr. Ioan Cantacuzino
      • Iași, Romania
        • Elena Doamna Obstetrics and Gynecology Clinical Hospital
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña
      • Barakaldo, Spain
        • Hospital Universitario de Cruces
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)
      • Barcelona, Spain
        • Hospital General Hospitalet CSI
      • Barcelona, Spain
        • Hospital Universitari Quiron Dexeus Barcelona
      • Barcelona, Spain
        • Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara (HUG)
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • Instituto Palacios, Salud y Medicina de la Mujer
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Málaga, Spain
        • Hospital Regional Universitario Carlos Haya
      • Toledo, Spain
        • Hospital Quironsalud Toledo
      • Valencia, Spain
        • Hospital Universitario y Politécnico La Fe
  • Sweden
      • Stockholm, Sweden
        • Danderyds Sjukhus AB
      • Stockholm, Sweden
        • Karolinska Institutet, Karolinska University Hospital Huddinge
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
      • Bolton, United Kingdom
        • Royal Bolton Hospital
      • Durham, United Kingdom
        • University Hospital of North Durham
      • Harrow, United Kingdom
        • London North West Healthcare NHS Trust
      • Hull, United Kingdom
        • Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust
      • Huntingdon, United Kingdom
        • Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • London, United Kingdom
        • North Middlesex University Hospital
      • London, United Kingdom
        • Queen Charlotte's & Chelsea Hospital
      • Manchester, United Kingdom
        • Royal Manchester Children'S Hospital - Manchester University Nhs Foundation Trust
      • Metropolitan Borough of Wirral, United Kingdom
        • Arrowe Park Hospital
      • Newcastle upon Tyne, United Kingdom
        • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
      • Preston, United Kingdom
        • Rosemere Cancer Centre - Royal Preston Hospital
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing
      • Southampton, United Kingdom
        • University Hospital Southampton NHS Foundation Trust
      • Stockton-on-Tees, United Kingdom
        • University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target study population will include women with moderate to severe symptoms of uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and subjects who were previously exposed to UPA 5 or 10 mg in Long Term Phase III clinical trials PGL09-027 (PEARL III extension; including patients of PGL11-024 (PEARL extension 2)), or PGL11-006 (PEARL IV).

Description

Inclusion Criteria:

  • Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and
  • Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and
  • Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study.

Exclusion criteria:

  • Patient is prescribed Esmya for pre-operative treatment
  • Patient has a contraindication to receive Esmya as per SmPC
  • Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment,
  • Patient has hypersensitivity to the active substance of Esmya or to one of its excipients,

  • Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study:

    • Patient is pregnant or plans to become pregnant within the next 12 months from treatment start,
    • Patient is breastfeeding,
    • Patient has genital bleeding of unknown aetiology or not due to uterine fibroids,
    • Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients treated with Esmya
Any patient who was confirmed as receiving one dose of Esmya

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Time Frame: Patients will be followed from baseline up to 60 months
Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Patients will be followed from baseline up to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Prescription pattern of Esmya in standard medical practice
Time Frame: Patients will be followed from baseline up to 60 months
Esmya use in patients
Patients will be followed from baseline up to 60 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PregLem SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pablo Arriagada, PregLem SA

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PGL14-001 (PREMIUM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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