Clinical Trial, Phase I
Conditions
Brief summary
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.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit * Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy * Pre-treatment cycle assessed as ovulatory and not longer than 44 days
Exclusion criteria
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal * Known or suspected liver disorders * Amenorrhea for more than 3 months within the last 6 months before the first screening examination * Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination) * Positive urine pregnancy test * Regular use of medicines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects without bleeding/spotting | After three month treatment | — |
| Hoogland score during treatment, day 63 to day 84 | Day 63 to 84 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations |
| Hoogland score during follow up cycle 1 | 4 weeks following treatment period | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations |
| Hoogland score during follow up cycle 2 | 4 weeks following follow up cycle 1 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations |
| Hoogland score during treatment, day 9 to day 28 | Day 9 to 28 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with TEAEs (treatment-emergent adverse events) | After three month treatment and during follow-up (up to 60 days) |
| Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes) | After three month treatment and during follow-up (up to 60 days) |
| Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling | After three month treatment |
Countries
Germany
Outcome results
None listed