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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2019

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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

    • 09 Aug 2019 Status changed from active, no longer recruiting to completed.
    • 17 Apr 2019 Planned End Date changed from 24 Jul 2019 to 1 Aug 2019.
    • 18 Mar 2019 Status changed from recruiting to active, no longer recruiting.
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