CompletedPhase 1

Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)

Germany71 participantsStarted 2017-07-17

Plain-language summary

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.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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 = 4

Timeframe: treatment day 57 to day 84

Trial details

NCT IDNCT03210246

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-21

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