Phase
Condition
Liver Disease
Treatment
ethinylestradiol/levonorgestrel
NNC0194-0499
Clinical Study ID
Ages 18-65 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female of non-childbearing potential.
Age 18-65 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.
Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests performed during the screening visit, as judged by theinvestigator.
Exclusion
Exclusion Criteria:
Any disorder which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol.
Any contraindications for the use of the oral contraception used in the studyaccording to the Prescription Drug Information.
Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
Pulse outside the range of 50-89 beats/minute at screening
Use of prescription medicinal products or non-prescription drugs including anyherbal medicine known to interfere with the metabolic CYP pathways, such ashypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins usedwithin a normal dose reference interval), occasional use of paracetamol,non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reachingsystemic circulation.
Presence or history of any clinically relevant respiratory, metabolic, renal,hepatic, gastrointestinal, or endocrinological conditions.
Study Design
Connect with a study center
Medical University of Graz
Graz, 8010
AustriaSite Not Available
Novo Nordisk Investigational Site
Graz, 8010
AustriaActive - Recruiting
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