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:

NCT02262663

EudraCT Number:

2014-000329-19

Study Completed

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
70
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 

Trial Design