NCT06188026

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. .

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Volunteers (Non-alcoholic Steatohepatitis)

Interventions

Type	Name	Description
DRUG	NNC0194-0499	Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin
DRUG	ethinylestradiol/levonorgestrel	Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.

Timeline

• Start date: 2023-12-18
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-01-03
• Last updated: 2025-02-18

Locations

1 site across 1 country: Austria