Trial Condition(s):
Clinical Trial, Phase I
Study in healthy young women to investigate the pharmacodynamics, pharmacokinetics and safety of vilaprisan
Bayer Identifier:
15818
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, parallel-group, multi-center study to investigate the pharmacodynamics, pharmacokinetics and safety after daily oral administration of 4 different doses of vilaprisan (BAY1002670) in healthy women of reproductive age
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Hoogland score during treatment, day 9 to day 28based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsTimeframe: Day 9 to 28
- Hoogland score during treatment, day 63 to day 84based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsTimeframe: Day 63 to 84
- Hoogland score during follow up cycle 1based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsTimeframe: 4 weeks following treatment period
- Hoogland score during follow up cycle 2based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsTimeframe: 4 weeks following follow up cycle 1
- Number of subjects without bleeding/spottingTimeframe: After three month treatment
Secondary Outcome
- Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modelingTimeframe: After three month treatment
- Number of subjects with TEAEs (treatment-emergent adverse events)Timeframe: After three month treatment and during follow-up (up to 60 days)
- Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)Timeframe: After three month treatment and during follow-up (up to 60 days)
Additional Information
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