A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components

Phase 2 Completed 177 enrolled Bayer

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women. It is designed to investigate the pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND), as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this study, Jaydess, as an LNG-only IUS, will be used as a comparator.

Timeline

Start: 2018-06-22
Primary completion: 2019-05-16
Completion: 2019-08-01

Publications

Hofmann BM, Ahola M, Fels LM, Klein S, Lindenthal B, Pihlaja J. Development of an Intrauterine Device Releasing Both Indomethacin and Levonorgestrel During the First Months of Use: Pharmacokinetic Characterization in Healthy Women. Clin Pharmacokinet. 2023 Jan;62(1):113-126. doi: 10.1007/s40262-022-01201-7. Epub 2023 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Indomethacin	Small molecule	6.5 mg	Other
Subject	Indomethacin	Small molecule	12.5 mg	Other
Subject	Indomethacin	Small molecule	15.4 mg	Other
Comparator	Levonorgestrel	Small molecule	13.5 mg	Other

Indications

No indication recorded.