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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)Timeframe: treatment day 57 to day 84
- Number of subjects with a Hoogland score = 4Timeframe: treatment day 57 to day 84
Additional Information
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