check_circleStudy Completed

Clinical Trial ,Phase I

Bayer Identifier:

17670

ClinicalTrials.gov Identifier:

NCT03210246

EudraCT Number:

2016-004532-38

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

Female

Age

18 - 35 Years
  • - 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)
  • - 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
July 2017 - January 2019
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany
Completed
Dinox GmbH BerlinBerlin, 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 = 4
    date_rangeTime Frame:
    treatment day 57 to day 84

Trial design

A randomized, double-blind, parallel-group, multi-center study to investigate the pharmacodynamics and pharmacokinetics of a combined oral contraceptive containing levonorgestrel (LNG) and ethinylestradiol (EE) when given together with vilaprisan over 3 months in healthy women of reproductive age
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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