Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Esmya under the microscope: is Long-Term use safe for fibroids?

NCT ID NCT02748460

Disease control Sponsor: PregLem SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed over 1,500 women with moderate to severe uterine fibroids who were taking Esmya (ulipristal acetate) long-term. Researchers tracked side effects, especially those affecting the uterus, and how doctors prescribed the drug in everyday practice. The goal was to better understand the safety of using Esmya in repeated courses over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esmya (ulipristal acetate)
What this could lead to
If successful, this study could confirm that long-term, intermittent use of Esmya is safe for managing uterine fibroids without surgery.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by how doctors prescribe the drug in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,527 people

The number who actually took part.

Started

Dec 2015

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Uterine fibroids are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine fibroids

Contacts and locations

Locations

  • A.O.Spedali Civili di Brescia

    Brescia, Italy

  • ARS

    Riga, Latvia

  • ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)

    Barcelona, Spain

  • Aarhus University Hospital

    Aarhus, Denmark

  • Ammerland Klinik GmbH

    Westerstede, Germany

  • Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

    Pavia, Italy

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, United Kingdom

  • Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte

    Siena, Italy

  • Azienda Usl Di Bologna

    Bologna, Italy

  • Centre Hospitalier Regional De La Citadelle

    Liège, Belgium

  • Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

    Tours, France

  • Centre Hospitalier Universitaire d'Angers

    Angers, France

  • Centre Hospitalier de Bethune

    Béthune, France

  • Centro hospitalar do Baixo vouga, EPE

    Aveiro, Portugal

  • Centrul Medical Euromed

    Bucharest, Romania

  • Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin

    Berlin, Germany

  • Clinica Jardim das Amoreiras

    Lisbon, Portugal

  • Clinique Universitaire de Mont Godinne

    Yvoir, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, Spain

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, Hungary

  • Danderyds Sjukhus AB

    Stockholm, Sweden

  • Dr Dvorak

    Brno, Czechia

  • Elena Doamna Obstetrics and Gynecology Clinical Hospital

    Iași, Romania

  • Endoskopie Und Endometriose-Zentrum Munchen

    München, Germany

  • Frauenarzt Bergedorf

    Hamburg, Germany

  • Frauenarztpraxis

    Frankfurt am Main, Germany

  • Frauenarztpraxis

    Köthen, Germany

  • Frauenarztpraxis Gluckstadt

    Glückstadt, Germany

  • Frauenarztpraxis Wandsbek

    Hamburg, Germany

  • G-Centrum Olomouc S.R.O.

    Olomouc, Czechia

  • Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw

    Warsaw, Poland

  • Gastroenheden Herlev-Gentofte

    Herlev, Denmark

  • Gemeinschaftspraxis der Frauenarztpraxis

    Deggendorf, Germany

  • Genesys Fertility Center

    Bucharest, Romania

  • Groupement Hospitalier Universitaire Sud CHU Bicetre

    Le Kremlin-Bicêtre, France

  • Gyn -Fsro

    Králová, Czechia

  • Gyn-Porodnicka Klinika Fn Brno

    Brno, Czechia

  • Gynakologische Praxis Klinik

    Bonn, Germany

  • Hellweg gynakologie/DOCX

    Geseke, Germany

  • Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital

    Huntingdon, United Kingdom

  • Hopital Bichat - Claude-Bernard

    Paris, France

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital General Hospitalet CSI

    Barcelona, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, Spain

  • Hospital Quironsalud Toledo

    Toledo, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, Spain

  • Hospital Universitari Quiron Dexeus Barcelona

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Spain

  • Hospital Universitario de Guadalajara (HUG)

    Guadalajara, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust

    Hull, United Kingdom

  • Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

    Barcelona, Spain

  • Instituto Palacios, Salud y Medicina de la Mujer

    Madrid, Spain

  • Josa Andras County Teaching Hospital

    Nyíregyháza, Hungary

  • Jsc Kardiolita

    Vilnius, Lithuania

  • Karolinska Institutet, Karolinska University Hospital Huddinge

    Stockholm, Sweden

  • Klinikum Bayreuth GmbH

    Bayreuth, Germany

  • Latvian Maritime Medicine Centre

    Riga, Latvia

  • Leicester General Hospital

    Leicester, United Kingdom

  • London North West Healthcare NHS Trust

    Harrow, United Kingdom

  • Medical Center Maxmeda

    Vilnius, Lithuania

  • Medplus Krefeld

    Krefeld, Germany

  • N. Lietuviete Private Practice

    Riga, Latvia

  • Norfolk and Norwich University Hospital

    Norwich, United Kingdom

  • North Middlesex University Hospital

    London, United Kingdom

  • PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie

    Cologne, Germany

  • Policlinico S. Orsola Malpighi

    Bologna, Italy

  • Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert

    Berlin, Germany

  • Praxisklinik Harburg

    Hamburg, Germany

  • Private Practice

    Prague, Czechia

  • Private Practice

    Dortmund, Germany

  • Private Practice

    Frankfurt, Germany

  • Private Practice

    Hamburg, Germany

  • Private Practice

    Plöcking, Germany

  • Private Practice

    Stolberg, Germany

  • Private Practice

    Riga, Latvia

  • Private Practice

    Coimbra, Portugal

  • Private Practice 2

    Prague, Czechia

  • Private practice

    Aachen, Germany

  • Private practice

    Ilsede, Germany

  • Private practice

    Ribnitz-Damgarten, Germany

  • Queen Charlotte's & Chelsea Hospital

    London, United Kingdom

  • Radboud Universitair Medical Center

    Nijmegen, Netherlands

  • Rethy Pal Hospital-Clinic Bekescsaba

    Békéscsaba, Hungary

  • RiGa 1st Hospital

    Riga, Latvia

  • Robert Karoly Maganklinika

    Budapest, Hungary

  • Rosemere Cancer Centre - Royal Preston Hospital

    Preston, United Kingdom

  • Royal Bolton Hospital

    Bolton, United Kingdom

  • Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

    Manchester, United Kingdom

  • Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust

    Stoke-on-Trent, United Kingdom

  • Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust

    Bath, United Kingdom

  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing

    Sheffield, United Kingdom

  • Spitalul Clinic Dr. Ioan Cantacuzino

    Bucharest, Romania

  • Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika

    Szeged, Hungary

  • Szent Anna Privat Surgery-Szent Anna Magae¡nrendela

    Debrecen, Hungary

  • Uherskohradistska Nemocnice A.S

    Uherské Hradiště, Czechia

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, Germany

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University ""Magna Graecia"" Of Catanzaro

    Catanzaro, Italy

  • University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust

    Stockton-on-Tees, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • University Hospital of North Durham

    Durham, United Kingdom

  • University of Bari Policlinico

    Bari, Italy

  • University of Torino, S. Anna Hospital- City of Health and Science

    Torino, Italy

  • Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie

    Hamburg, Germany

  • Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche

    Ancona, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.