Clinical Trial ,Phase I
Conditions
Brief summary
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.
Interventions
DRUGVilaprisan (BAY 1002670)
Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
DRUGVilaprisan Placebo
Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
DRUGMicrogynon
Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)
DRUGMicrogynon Placebo
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).
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female premenopausal subjects * Age: 18 to 35 years (inclusive) * Body mass index (BMI) : ≥18 and ≤30 kg/m² * Non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included)
Exclusion criteria
* Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal * presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5) | treatment day 57 to day 84 |
| Number of subjects with a Hoogland score = 4 | treatment day 57 to day 84 |
Countries
Germany
Outcome results
None listed