Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
174
Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)
Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day
Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day
Unnamed facility
Hanover, Lower Saxony, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Number of bleeding and spotting days
Time frame: Daily recorded during 90 days treatment period
Progestin effects on endometrial histology
Endometrail histology will be evaluated according to standardized criteria, derived from Blaustein's standard pathology textbook and criteria for secretory-type effects caused by exogenous progestins after intrauterine application.
Time frame: Data derived from biopsies taken in the pre-treatment cycle, under treatment (between day 42 and day 90 of treatment) and during follow-up (within max. 40 days after IUS removal).
Ovulation(Yes/no)
Time frame: Treatment period 90 days
Endometrial thickness
Time frame: pre-treatment cycle days 6, 9, 12, 15, 18, 21, 24, 27, 30, treatment period days 1, 13, 27, 41, 44, 48, 51, 55, 58, 62, 65, 69, 72, 76, 79, 83, 86, 90
Bleeding characterization (Intensity, pattern)
Classified using a 5-step scale from "none" to "heavy"
Time frame: For 90 day treatment period
Serum levels of estradiol
Time frame: Repeatedly under 90 day treatment
Serum levels of progesterone
Time frame: Repeatedly under 90 day treatment
Serum levels of luteinizing hormone
Time frame: Repeatedly under 90 day treatment
Serum levels of follicle-stimulating hormone
Time frame: Repeatedly under 90 day treatment
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Hamburg, Germany
Unnamed facility
Groningen, Netherlands
Unnamed facility
Belfast, United Kingdom
Cervix function (Insler score)
The cervix function is classified using the 4-step Insler Score
Time frame: cycle day 6,9,12,15,18,23,24,27,40, treatment period days 41,44,48,51,55,58,62,65,69,76,79,80,83,90
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: up to 5 months
Cmax of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,
AUC of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
T1/2 of BAY1007626
Time frame: treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95