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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with Esmya |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation. | Patients will be followed from baseline up to 15 months |
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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:
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The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Oliver, MD | PregLem SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Klagenfurt | Klagenfurt | Austria | ||||
| Private practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28676450 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2019 | |
| Reset | Jun 27, 2019 | |
| Release | Aug 29, 2019 |
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| Sankt Pölten |
| Austria |
| CHU Pellegrin Gynécologie | Bordeaux | France |
| Hopital Bicetre | Le Kremlin-Bicètre | France |
| CHU La Conception | Marseille | France |
| CHU Hôpital Mère-enfant | Nantes | France |
| Tenon CHU Paris Est | Paris | France |
| CHUV Maison Blanche Institut | Reims | France |
| CHU Anne de Bretagne | Rennes | France |
| CHU Tours Gynécologie | Tours | France |
| Universitätsklinikum Aachen | Aachen | Germany |
| Klinik am Hofgarten | Bayreuth | Germany |
| Charite | Berlin | Germany |
| Private practice | Berlin | Germany |
| Medizinisches Zentrum Bonn Friedensplatz | Bonn | Germany |
| Private Practice | Bruchsal | Germany |
| Private practice | Cologne | Germany |
| Private Practice | Diepholz | Germany |
| Private practive | Dorsten | Germany |
| Private practice | Dortmund | Germany |
| Frauenklinik, Universitätsklinikum Erlangen | Erlangen | Germany |
| Klinikum Esslingen | Esslingen am Neckar | Germany |
| Universitäts Frauenklinik | Freiburg im Breisgau | Germany |
| Gynäkologische Praxis | Geseke | Germany |
| Hormonzentrum Altonaerstrasse | Hamburg | Germany |
| Gynaekologische Praxisklinik Harburger Ring | Harburg | Germany |
| Private practice | Hoyerswerda | Germany |
| Private practice | Ilsede | Germany |
| Private practice | Krefeld | Germany |
| Gynäkologische Praxis | Mainz | Germany |
| Endoskopie und Endometriose Zentrum | München | Germany |
| Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde | München | Germany |
| Private practice | Rodgau | Germany |
| Fachaerzte fuer Frauenheilkunde und Geburtshilfe | Rotenburg (Wümme) | Germany |
| Private practice | Völklingen | Germany |
| Semmelweis University Faculty of Medicine | Budapest | Hungary |
| University of Pécs Medical school | Pécs | Hungary |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi | Bologna | Italy |
| Universita di Cagliari | Cagliari | Italy |
| Azienda Ospedaliera Garibaldi-Nesima | Catania | Italy |
| Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna | Cona | Italy |
| Università degli Studi di Firenze | Florence | Italy |
| Clinica ospedale san martino e cliniche universitarie convenzionate di genova | Genova | Italy |
| IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano | Milan | Italy |
| La Sapienza University | Roma | Italy |
| Ospedale Mauriziano "Umberto I" | Torino | Italy |
| Private practice | Kętrzyn | Poland |
| Private practice | Komorów | Poland |
| Private practice | Lublin | Poland |
| Private Practice | Opole | Poland |
| Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa | Płock | Poland |
| Centrum Zdrowia mama i Ja | Wroclaw | Poland |
| Gabinet Ginekologiczny | Żory | Poland |
| Hospital do Espirito santo de Évora | Evora | Portugal |
| Hospital da Luz-Lisboa | Lisbon | Portugal |
| Spitalul Clinic de Urgenta Militar Central | Bucharest | Romania |
| OG Clinic II " Dominic Stanca " | Cluj-Napoca | Romania |
| Spitalul Clinic de Urgenta | Târgu Mureş | Romania |
| Hospital del Mar | Barcelona | Spain |
| Hospital Sant Pau | Barcelona | Spain |
| Hospital de la Zarzuela | Madrid | Spain |
| Hospital Virgen de la Macarena | Seville | Spain |
| Hospital Virgen de la Salud | Toledo | Spain |
| Bradford Royal Infirmary | Bradford | United Kingdom |
| North Cumbria University Hospitals NHS Trust | Carlisle | United Kingdom |
| Hull and East Yorshire Eye Hospital | East Yorkshire | United Kingdom |
| Epsom & St Helier University Hospitals NHS Trust | Epsom Surrey | United Kingdom |
| Royal devon and Exeter hospital | Exeter | United Kingdom |
| Royal Hampshire County Hospital | Hampshire | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
| Liverpool Womens hospital | Liverpool | United Kingdom |
| Barts and The London School of Medicine | London | United Kingdom |
| King's College Hospital NHS Foundation | London | United Kingdom |
| Nottingham University Hospital NHS trust | Nottingham | United Kingdom |
| Southampton University Hospital | Southampton | United Kingdom |
| Reset | Sep 26, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2019 | Jun 27, 2019 | |||
| Aug 29, 2019 | Sep 26, 2019 |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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