Status:
COMPLETED
A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers (Non-alcoholic Steatohepatitis)
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets...
Eligibility Criteria
Inclusion
- 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, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any contraindications for the use of the oral contraception used in the study according 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 any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06188026
Start Date
December 18 2023
End Date
December 30 2024
Last Update
February 18 2025
Active Locations (1)
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1
Medical University of Graz
Graz, Austria, 8010