check_circleStudy Completed
Clinical Trial ,Phase I
Bayer Identifier:
17670
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Drug-drug interaction study: influence of vilaprisan on pharmacodynamics (PD) and pharmacokinetics (PK) of a combined oral contraceptive (COC)
Trial purpose
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
71Trial Dates
July 2017 - January 2019Phase
Phase 1Could I Receive a placebo
YesProducts
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
- Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)date_rangeTime Frame:treatment day 57 to day 84
- Number of subjects with a Hoogland score = 4date_rangeTime Frame:treatment day 57 to day 84
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2