Study 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

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

October 2014 - December 2015

Phase

Phase 1

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany
Completed	Dinox GmbH Berlin	Berlin, 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
Time Frame:
Day 9 to 28
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
Time Frame:
Day 63 to 84
Safety Issue:
No
Hoogland score during follow up cycle 1
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time Frame:
4 weeks following treatment period
Safety Issue:
No
Hoogland score during follow up cycle 2
based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
Time Frame:
4 weeks following follow up cycle 1
Safety Issue:
No
Number of subjects without bleeding/spotting
Time Frame:
After three month treatment
Safety Issue:
No

Secondary Outcome

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.