check_circleStudy Completed
Clinical Trial, Phase I
Bayer Identifier:
15818
ClinicalTrials.gov Identifier:
EudraCT Number:
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
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
70Trial Dates
October 2014 - December 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
YesWhere 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 28based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsdate_rangeTime Frame:Day 9 to 28enhanced_encryptionNoSafety Issue:
- Hoogland score during treatment, day 63 to day 84based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsdate_rangeTime Frame:Day 63 to 84enhanced_encryptionNoSafety Issue:
- Hoogland score during follow up cycle 1based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsdate_rangeTime Frame:4 weeks following treatment periodenhanced_encryptionNoSafety Issue:
- Hoogland score during follow up cycle 2based on maximum size of follicle-like structures, estradiol and progesterone serum concentrationsdate_rangeTime Frame:4 weeks following follow up cycle 1enhanced_encryptionNoSafety Issue:
- Number of subjects without bleeding/spottingdate_rangeTime Frame:After three month treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modelingdate_rangeTime Frame:After three month treatmentenhanced_encryptionNoSafety Issue:
- 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_encryptionYesSafety Issue:
- 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_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4