Status:
COMPLETED
Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan
Lead Sponsor:
Bayer
Conditions:
Clinical Trial, Phase I
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
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 diffe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02262663
Start Date
October 1 2014
End Date
December 1 2015
Last Update
March 16 2016
Active Locations (2)
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1
Berlin, State of Berlin, Germany, 10115
2
Berlin, State of Berlin, Germany, 13353