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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
177
Active ingredient content (in mg IND/LNG): low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5
Comparative LNG dose
Nuvisan GmbH
Neu-Ulm, Bavaria, Germany
Frauenarztpraxis Dr. Wetzel
Blankenburg, Saxony-Anhalt, Germany
Dinox GmbH Berlin
Berlin, Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
CTC North GmbH & Co. KG
Hamburg, Germany
Praxis Hr. Dr. K. Peters
Hamburg, Germany
PAREXEL International Early Phase Clinical Unit (London)
Harrow, United Kingdom
Number of uterine bleeding/spotting (B/S) days during treatment
Recorded by participants with electronic diary
Time frame: 90 days after start of treatment
Number of subjects showing endometrial histology typical for intrauterine LNG application in biopsies taken at the end of treatment
Time frame: On day 90 after start of treatment
Frequency of treatment emergent adverse events
Time frame: 90 days after start of treatment
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