ASTEROID 5 (version 1.0)

• Research type

  Research Study

• Full title

  A randomised, parallel-group, double-blind, double-dummy, active-controlled, multicentre study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids.

• IRAS ID

  226900

• Contact name

  Yogesh Deshmukh

• Contact email

  yogesh.deshmukh@bayer.com

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2016-002855-48

• Duration of Study in the UK

  4 years, 1 months, 29 days

• Research summary

  Summary of Research
  The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

  The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

  Summary of Results
  Plain language summary of results is under development and will be posted on Bayer Clinical Trial Explorer by 25 Oct 2022.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  17/SC/0244

• Date of REC Opinion

  27 Jul 2017

• REC opinion

  Further Information Favourable Opinion