BAY 1007626 Proof-of-Concept/Dose Finding Study.

• Research type

  Research Study

• Full title

  Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system releasing BAY 1007626, as compared with Mirena and Jaydess, in a combined proof-of-concept and dose-finding study in healthy pre-menopausal women treated for 90 days.

• IRAS ID

  179805

• Sponsor organisation

  BioKinetic Europe Ltd

• Eudract number

  2013-003980-74

• Duration of Study in the UK

  1 years, 1 months, 25 days

• Research summary

  This is a multicentre study to investigate the pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY 1007626 in comparison to Mirena® and Jaydess® in healthy young women (aged 18 to 40) treated for 90 days to determine the drug dose for further development.

  The study drug is an intrauterine system releasing BAY 1007626, a synthetic hormone with progesterone-like effects. It is being developed for use as an intrauterine system (IUS) for long-acting contraception, commonly known as a ‘coil’.

  Progesterone is a female sex hormone, which plays an important role during pregnancy and is produced during the second half of the menstrual cycle. BAY 1007626 binds to the progesterone receptor and could therefore prevent pregnancy. The study drug will be compared with the marketed intrauterine systems, Mirena® and Jaydess®.

  To compare the new study drug to an existing drug, some subjects will receive Mirena® or Jaydess®. Both are marketed approved intrauterine levonorgestrel releasing systems with known contraceptive properties.

  Approximately 176 subjects will take part in in the study in 3 European countries: Germany, The Netherlands and the UK. They will receive either BAY 1007626 in one of 4 different doses, Mirena® or Jaydess®.
  
  A subgroup (around one half) of the subjects will undergo a more thorough analysis, and will participate on a dense study visit basis. The other subjects will have fewer study visits (weekly during treatment) and undergo fewer tests.

  The study is divided into 4 periods: screening, pre-treatment cycle, treatment cycles & follow-up. The overall study participation will be approximately 7 months.

• REC name

  HSC REC B

• REC reference

  15/NI/0079

• Date of REC Opinion

  28 May 2015

• REC opinion

  Further Information Favourable Opinion