check_circleStudy Completed

Clinical Trial, Phase I

Bayer Identifier:

15818

ClinicalTrials.gov Identifier:

NCT02262663

EudraCT Number:

2014-000329-19

EU CT Number:

Not Available
Study in healthy young women to investigate the pharmacodynamics, pharmacokinetics and safety of vilaprisan

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.

Key Participants Requirements

Sex

Female

Age

18 - 40 Years
  • - 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
  • - 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
70
Trial Dates
October 2014 - December 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany
Completed
Dinox GmbH BerlinBerlin, 10115, Germany

Primary Outcome

  • Hoogland score during treatment, day 9 to day 28
    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
    date_rangeTime Frame:
    Day 9 to 28
    enhanced_encryption
    Safety Issue:
    No
  • Hoogland score during treatment, day 63 to day 84
    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
    date_rangeTime Frame:
    Day 63 to 84
    enhanced_encryption
    Safety Issue:
    No
  • Hoogland score during follow up cycle 1
    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
    date_rangeTime Frame:
    4 weeks following treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Hoogland score during follow up cycle 2
    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
    date_rangeTime Frame:
    4 weeks following follow up cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects without bleeding/spotting
    date_rangeTime Frame:
    After three month treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
    date_rangeTime Frame:
    After three month treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with TEAEs (treatment-emergent adverse events)
    date_rangeTime Frame:
    After three month treatment and during follow-up (up to 60 days)
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
    date_rangeTime Frame:
    After three month treatment and during follow-up (up to 60 days)
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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