This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
71
Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)
Dinox GmbH Berlin
Berlin, Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
Time frame: treatment day 57 to day 84
Number of subjects with a Hoogland score = 4
Time frame: treatment day 57 to day 84
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For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).