This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
70
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Hoogland score during treatment, day 9 to day 28
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time frame: Day 9 to 28
Hoogland score during treatment, day 63 to day 84
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time frame: Day 63 to 84
Hoogland score during follow up cycle 1
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time frame: 4 weeks following treatment period
Hoogland score during follow up cycle 2
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time frame: 4 weeks following follow up cycle 1
Number of subjects without bleeding/spotting
Time frame: After three month treatment
Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
Time frame: After three month treatment
Number of subjects with TEAEs (treatment-emergent adverse events)
Time frame: After three month treatment and during follow-up (up to 60 days)
Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
Time frame: After three month treatment and during follow-up (up to 60 days)
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