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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Medical University of Graz
Graz, Austria
(AUC0-24h,EE,SS), area under the ethinylestradiol plasma concentration-time curve during a dosing interval at steady state
h-pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(AUC0-24h,LN,SS), area under the levonorgestrel plasma concentration-time curve during a dosing interval at steady state
h-pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(Cmax,EE,SS), maximum concentration of ethinylestradiol at steady state
pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(Cmax,LN,SS), maximum concentration of levonorgestrel at steady state
pg/mL
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,EE,SS), time to maximum concentration of ethinylestradiol at steady state
hours
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
(tmax,LN,SS), time to maximum concentration of levonorgestrel at steady state
hours
Time frame: Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)
Number of treatment emergent adverse events (TEAEs)
Number of events
Time frame: Day 1 to Day 8, and Day 31 to Day 38.
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