Uterine FibroidsPremiumNCT02748460
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
An observational study of Uterine Fibroids, run by PregLem SA at 115 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- How many people
- 1,527 participants
- Where
- 115 sitesin 16 countries
- Study dates
- 22 Dec 2015to 11 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
115 sites in 16 countries.
115 sites in 16 countries
Germany26 sites
Private practice
Aachen
Klinikum Bayreuth GmbH
Bayreuth
Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin
Berlin
Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert
Berlin
Gynakologische Praxis Klinik
Bonn
PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie
Cologne
Gemeinschaftspraxis der Frauenarztpraxis
Deggendorf
Private Practice
Dortmund
Private Practice
Frankfurt
Frauenarztpraxis
Frankfurt am Main
Hellweg gynakologie/DOCX
Geseke
Universitaetsklinikum Giessen und Marburg GmbH
Giessen
Frauenarztpraxis Gluckstadt
Glückstadt
Frauenarzt Bergedorf
Hamburg
Frauenarztpraxis Wandsbek
Hamburg
Praxisklinik Harburg
Hamburg
Private Practice
Hamburg
Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie
Hamburg
Private practice
Ilsede
Frauenarztpraxis
Köthen
Medplus Krefeld
Krefeld
Endoskopie Und Endometriose-Zentrum Munchen
München
Private Practice
Plöcking
Private practice
Ribnitz-Damgarten
Private Practice
Stolberg
Ammerland Klinik GmbH
Westerstede
Spain20 sites
Complejo Hospitalario Universitario A Coruna
A Coruña
Hospital Universitario de Cruces
Barakaldo
ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital General Hospitalet CSI
Barcelona
Hospital Universitari Quiron Dexeus Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitario de Guadalajara (HUG)
Guadalajara
Hospital Clinico San Carlos
Madrid
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Instituto Palacios, Salud y Medicina de la Mujer
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Regional Universitario Carlos Haya
Málaga
Hospital Quironsalud Toledo
Toledo
Hospital Universitario y Politecnico La Fe
Valencia
United Kingdom18 sites
Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust
Bath
Royal Bolton Hospital
Bolton
University Hospital of North Durham
Durham
London North West Healthcare NHS Trust
Harrow
Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust
Hull
Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital
Huntingdon
Leicester General Hospital
Leicester
North Middlesex University Hospital
London
Queen Charlotte's & Chelsea Hospital
London
Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust
Manchester
Arrowe Park Hospital
Metropolitan Borough of Wirral
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Norfolk and Norwich University Hospital
Norwich
Rosemere Cancer Centre - Royal Preston Hospital
Preston
Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing
Sheffield
University Hospital Southampton NHS Foundation Trust
Southampton
University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust
Stockton-on-Tees
Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust
Stoke-on-Trent
Italy9 sites
Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche
Ancona
University of Bari Policlinico
Bari
Azienda Usl Di Bologna
Bologna
Policlinico S. Orsola Malpighi
Bologna
A.O.Spedali Civili di Brescia
Brescia
University ""Magna Graecia"" Of Catanzaro
Catanzaro
Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
Pavia
Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte
Siena
University of Torino, S. Anna Hospital- City of Health and Science
Torino
Czechia7 sites
Dr Dvorak
Brno
Gyn-Porodnicka Klinika Fn Brno
Brno
Gyn -Fsro
Králová
G-Centrum Olomouc S.R.O.
Olomouc
Private Practice 2
Prague
Private Practice
Prague
Uherskohradistska Nemocnice A.S
Uherské Hradiště
Hungary6 sites
Rethy Pal Hospital-Clinic Bekescsaba
Békéscsaba
Robert Karoly Maganklinika
Budapest
Szent Anna Privat Surgery-Szent Anna Magae¡nrendela
Debrecen
Josa Andras County Teaching Hospital
Nyíregyháza
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika
Szeged
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes
France5 sites
Centre Hospitalier Universitaire d'Angers
Angers
Centre Hospitalier de Bethune
Béthune
Groupement Hospitalier Universitaire Sud CHU Bicetre
Le Kremlin-Bicêtre
Hopital Bichat - Claude-Bernard
Paris
Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
Tours
Latvia5 sites
ARS
Riga
Latvian Maritime Medicine Centre
Riga
N. Lietuviete Private Practice
Riga
Private Practice
Riga
RiGa 1st Hospital
Riga
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels
Universitair Ziekenhuis Gent
Ghent
Centre Hospitalier Regional De La Citadelle
Liège
Clinique Universitaire de Mont Godinne
Yvoir
Romania4 sites
Centrul Medical Euromed
Bucharest
Genesys Fertility Center
Bucharest
Spitalul Clinic Dr. Ioan Cantacuzino
Bucharest
Elena Doamna Obstetrics and Gynecology Clinical Hospital
Iași
Portugal3 sites
Centro hospitalar do Baixo vouga, EPE
Aveiro
Private Practice
Coimbra
Clinica Jardim das Amoreiras
Lisbon
Denmark2 sites
Aarhus University Hospital
Aarhus
Gastroenheden Herlev-Gentofte
Herlev
Sweden2 sites
Danderyds Sjukhus AB
Stockholm
Karolinska Institutet, Karolinska University Hospital Huddinge
Stockholm
Poland1 site
Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw
Warsaw
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Esmya | Any patient who was confirmed as receiving one dose of Esmya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
Measured: Patients will be followed from baseline up to 60 months
Secondary outcomes (1)
Assessment of Prescription pattern of Esmya in standard medical practice
Esmya use in patients
Measured: Patients will be followed from baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start22 Dec 2015
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Arriagada, Study director, PregLem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748460
- Sponsor's protocol ID
- PGL14-001 (PREMIUM)
- Acronym
- Premium
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2016
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02748460
- Acronym / sponsor ID
- Premium / PGL14-001 (PREMIUM)
- Conditions
- Uterine Fibroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,527 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Esmya | – | –Any patient who was confirmed as receiving one dose of Esmya |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Assessment of Prescription pattern of Esmya in standard medical practice
Time frame: Patients will be followed from baseline up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Arriagada study director
PregLem SA
115 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by PregLem SA at 115 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in Germany, Spain, United Kingdom, Italy, Czechia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.