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Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system (BAY 987443) with three different release rates of indomethacin and one release rate of levonorgestrel, as compared with Jaydess, in a combined proof-of-concept and dose finding study in healthy pre-menopausal women treated for 90 days

Trial Profile

Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system (BAY 987443) with three different release rates of indomethacin and one release rate of levonorgestrel, as compared with Jaydess, in a combined proof-of-concept and dose finding study in healthy pre-menopausal women treated for 90 days

Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Dec 2018

At a glance

  • Drugs Indometacin (Primary) ; Indometacin+levonorgestrel (Primary) ; Levonorgestrel (Primary)
  • Indications Pregnancy
  • Focus Proof of concept; Therapeutic Use
  • Acronyms INDessa
  • Sponsors Bayer
  • Most Recent Events

    • 05 Jul 2018 Planned End Date changed from 27 Aug 2019 to 24 Jul 2019.
    • 05 Jul 2018 Status changed from Not yet recruiting to recruiting.
    • 24 May 2018 New trial record
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