Uterine FibroidsPREMYANCT01635452
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
An observational study of Uterine Fibroids, run by PregLem SA at 75 sites in 10 countries.
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. 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
- 1,500 participants
- Where
- 75 sitesin 10 countries
- Study dates
- May 2012to Mar 2016
- 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 who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
Who may be able to join
- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.
Who cannot join
- 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
Trial locations and contacts
75 sites in 10 countries.
75 sites in 10 countries
Germany25 sites
Universitätsklinikum Aachen
Aachen
Klinik am Hofgarten
Bayreuth
Charite
Berlin
Private practice
Berlin
Medizinisches Zentrum Bonn Friedensplatz
Bonn
Private Practice
Bruchsal
Private practice
Cologne
Private Practice
Diepholz
Private practive
Dorsten
Private practice
Dortmund
Frauenklinik, Universitätsklinikum Erlangen
Erlangen
Klinikum Esslingen
Esslingen am Neckar
Universitäts Frauenklinik
Freiburg im Breisgau
Gynäkologische Praxis
Geseke
Hormonzentrum Altonaerstrasse
Hamburg
Gynaekologische Praxisklinik Harburger Ring
Harburg
Private practice
Hoyerswerda
Private practice
Ilsede
Private practice
Krefeld
Gynäkologische Praxis
Mainz
Endoskopie und Endometriose Zentrum
München
Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde
München
Private practice
Rodgau
Fachaerzte fuer Frauenheilkunde und Geburtshilfe
Rotenburg (Wümme)
Private practice
Völklingen
United Kingdom12 sites
Bradford Royal Infirmary
Bradford
North Cumbria University Hospitals NHS Trust
Carlisle
Hull and East Yorshire Eye Hospital
East Yorkshire
Epsom & St Helier University Hospitals NHS Trust
Epsom Surrey
Royal devon and Exeter hospital
Exeter
Royal Hampshire County Hospital
Hampshire
University Hospitals of Leicester NHS Trust
Leicester
Liverpool Womens hospital
Liverpool
Barts and The London School of Medicine
London
King's College Hospital NHS Foundation
London
Nottingham University Hospital NHS trust
Nottingham
Southampton University Hospital
Southampton
Italy9 sites
Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi
Bologna
Universita di Cagliari
Cagliari
Azienda Ospedaliera Garibaldi-Nesima
Catania
Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna
Cona
Università degli Studi di Firenze
Florence
Clinica ospedale san martino e cliniche universitarie convenzionate di genova
Genova
IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano
Milan
La Sapienza University
Roma
Ospedale Mauriziano "Umberto I"
Torino
France8 sites
CHU Pellegrin Gynécologie
Bordeaux
Hopital Bicetre
Le Kremlin-Bicètre
CHU La Conception
Marseille
CHU Hôpital Mère-enfant
Nantes
Tenon CHU Paris Est
Paris
CHUV Maison Blanche Institut
Reims
CHU Anne de Bretagne
Rennes
CHU Tours Gynécologie
Tours
Poland7 sites
Private practice
Kętrzyn
Private practice
Komorów
Private practice
Lublin
Private Practice
Opole
Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa
Płock
Centrum Zdrowia mama i Ja
Wroclaw
Gabinet Ginekologiczny
Żory
Spain5 sites
Hospital del Mar
Barcelona
Hospital Sant Pau
Barcelona
Hospital de la Zarzuela
Madrid
Hospital Virgen de la Macarena
Seville
Hospital Virgen de la Salud
Toledo
Romania3 sites
Spitalul Clinic de Urgenta Militar Central
Bucharest
OG Clinic II " Dominic Stanca "
Cluj-Napoca
Spitalul Clinic de Urgenta
Târgu Mureş
Hungary2 sites
Semmelweis University Faculty of Medicine
Budapest
University of Pécs Medical school
Pécs
Portugal2 sites
Hospital do Espirito santo de Évora
Evora
Hospital da Luz-Lisboa
Lisbon
About this study
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
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
Measured: Patients will be followed from baseline up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2014
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Oliver, MD, Study director, PregLem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635452
- Sponsor's protocol ID
- PGL10-014
- Acronym
- PREMYA
- Status last verified
- Jan 2015
- First submitted
- 26 Jun 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez H, Descamps P, Koskas M, Lopes P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.
PubMed 28676450
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01635452
- Acronym / sponsor ID
- PREMYA / PGL10-014
- Conditions
- Uterine Fibroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 9 Jul 2012 (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-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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with 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 who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
Key inclusion criteria (1 listed)
- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.
Key exclusion criteria (6 listed)
- 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,
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 28676450Fernandez H, Descamps P, Koskas M, Lopes P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.
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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.
Jaime Oliver, MD study director
PregLem SA
75 sites in 10 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 75 sites in 10 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Germany, United Kingdom, Italy, France, Poland and 5 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?
Results are not available in the source record.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635452, which also lists 1 linked publication.
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 27 Jan 2015.