Esmya ® Prescription Patterns in Europe_protocol version 4.0
Research type
Research Study
Full title
Esmya ® Prescription Patterns in Europe: A Retrospective Drug Utilization Chart Review Study
IRAS ID
160442
Contact name
Edward Morris
Contact email
Sponsor organisation
PregLem S.A.
Clinicaltrials.gov Identifier
Dated 06 June 2014, Amendment No. 1, General
Research summary
This is a multi-national, multi-centre study involving the retrospective review of real world Esmya ® drug utilisation patterns. Esmya ® 5mg tablets are taken orally once daily for the per-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. At least 260 prescribers of Esmya ® will be recruited from 5 European countries (United Kingdom [UK], France, Germany, Spain, and Italy) following each country-specific product launch. The study aims to ensure data collection from at least 200 treated patients in each country. Eligible patients will be contacted by the site and will be asked to provide informed consent prior to enrollment in study. From patient medical charts, pseudonymised clinical data pertaining to demographics, diagnosis, gynaecological history including previous treatment (medical or surgical), and Esmya ® prescription, will be extracted and entered by site study staff into an electronic data capture (EDC) database. For all patients enrolled, at least 15 months of follow-up data after start of Esmya® treatment will be collected. As required during the Marketing Authorisation approval process, in order to further validate the conclusion of this study, the most suitable national databases will be interrogated at the time of interim and final analysis of the Prescription Pattern study with the results of these interrogations appended to the Study Reports.
Due to the retrospective nature, this study involves no intervention, does not interfere with usual medical care, will not affect the treatment of patients and hence will collect data fully reflecting the usual medical practice.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1328
Date of REC Opinion
18 Jul 2014
REC opinion
Favourable Opinion