Medical University of Graz
Graz, 8010, Austria
NCT Number: NCT06188026
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.
Looking for future studies?
Notify Me18 year–65 year
Female
Interventional
Phase 1
Graz, 8010, Austria
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin
Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
h-pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
hours
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
hours
Time frame: Day 1 to Day 8, and Day 31 to Day 38.
Number of events
Novo Nordisk A/S
Industry
Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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