ASTEROID 2

• Research type

  Research Study

• Full title

  A randomised, parallel-group, double-blind placebo-controlled and open label active-controlled, multi-centre study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

• IRAS ID

  173072

• Contact name

  Yogesh Deshmukh

• Contact email

  yogesh.deshmukh@bayer.com

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2014-004221-41

• Duration of Study in the UK

  1 years, 8 months, 0 days

• Research summary

  The study is perfomed to assess the efficacy of BAY1002670/Vilaprisan in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0239

• Date of REC Opinion

  18 May 2015

• REC opinion

  Further Information Favourable Opinion