NCT06188026CompletedPhase 1
A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.
Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
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 in two periods of 8 days each. Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks. The study will last for about 11 to 15 weeks, depending on the length of the screening period. Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 14 Dec 2023
- Start date
- 18 Dec 2023
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Novo Nordisk A/S
- NCT number
- NCT06188026
- EU CT number
- 2023-503595-24-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 34
- From 18 Dec 2023 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindications for the use of the oral contraception used in the study according to the Prescription Drug Information.
- 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.
Other illness
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.