Trial Condition(s):

Clinical Trial ,Phase I

Drug-drug interaction study: influence of vilaprisan on pharmacodynamics (PD) and pharmacokinetics (PK) of a combined oral contraceptive (COC)

Bayer Identifier:

17670

ClinicalTrials.gov Identifier:

NCT03210246

EudraCT Number:

2016-004532-38

Study Completed

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.

Inclusion Criteria
- Healthy female premenopausal subjects
 - Age: 18 to 35 years (inclusive) 
 - Body mass index (BMI) : ≥18 and ≤30 kg/m²
 - Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Exclusion Criteria
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
- presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident

Trial Summary

Enrollment Goal
71
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
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