Medabon PASS

• Research type

  Research Study

• Full title

  POST-AUTHORISATION SURVEILLANCE STUDY OF THE EFFICACY AND SAFETY OF MEDABON(MIFEPRISTONE/MISOPROSTOL) FOR EARLY PREGNANCY TERMINATION

• IRAS ID

  158431

• Contact name

  Gillian Flett

• Contact email

  gillian.flett@nhs.net

• Sponsor organisation

  Sun Pharmaceutical Industries Europe B.V.

• Research summary

  This is an open-label, non-interventional, prospective, observational, post authorization study of the outcomes and safety associated with the use of Medabon for the medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea. This study is designed to obtain descriptive information on the safety and efficacy of Medabon in women undergoing termination of early
  pregnancy, and to evaluate and compare the emergency evacuation rate, continuing pregnancy rate and requirement for surgical intervention to the historical rates for this combination treatment.
  Subjects requesting medical abortion for which treatment with mifepristone/misoprostol is medically appropriate will be treated with Medabon per institutional practice and according to the European Summary of Product Characteristics, and followed for at least 14 days for treatment outcome, adverse events, and the requirement for other subsequent interventional treatment.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  14/NS/1053

• Date of REC Opinion

  29 Oct 2014

• REC opinion

  Further Information Favourable Opinion