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
Overview
- Phase
- Phase 1
- Intervention
- Vilaprisan (BAY1002670)
- Conditions
- Clinical Trial, Phase I
- Sponsor
- Bayer
- Enrollment
- 70
- Primary Endpoint
- Number of subjects without bleeding/spotting
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Vilaprisan [0.5mg]
0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Intervention: Vilaprisan (BAY1002670)
Vilaprisan [1mg]
1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Intervention: Vilaprisan (BAY1002670)
Vilaprisan [2mg]
2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Intervention: Vilaprisan (BAY1002670)
Vilaprisan [4mg]
4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Intervention: Vilaprisan (BAY1002670)
Outcomes
Primary Outcomes
Number of subjects without bleeding/spotting
Time Frame: After three month treatment
Hoogland score during treatment, day 63 to day 84
Time Frame: Day 63 to 84
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during follow up cycle 1
Time Frame: 4 weeks following treatment period
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during treatment, day 9 to day 28
Time Frame: Day 9 to 28
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Hoogland score during follow up cycle 2
Time Frame: 4 weeks following follow up cycle 1
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Secondary Outcomes
- Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)(After three month treatment and during follow-up (up to 60 days))
- Number of subjects with TEAEs (treatment-emergent adverse events)(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)