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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

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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: 20 Jan 2023

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At a glance

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

Most Recent Events

  • 17 Jan 2023 Results of Pharmacokinetic parameter , published in the Clinical Pharmacokinetics
  • 29 Oct 2022 Results assessing The effect of a combined indomethacin and levonorgestrel-releasing intrauterine system on short-term postplacement bleeding profile published in the American Journal of Obstetrics and Gynecology
  • 09 Aug 2019 Status changed from active, no longer recruiting to completed.

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