This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.
Novo Nordisk Investigational Site
Neuss, Germany
Area under the ethinylestradiol concentration-time curve
Time frame: in the 24 hour dosing interval
Area under the levonorgestrel concentration-time curve
Time frame: in the 24 hour dosing interval
Maximum oral contraceptive concentration
Time frame: in the 24 hour dosing interval
Area under the semaglutide concentration-time curve
Time frame: in the 24 hour dosing interval
Maximum semaglutide concentration
Time frame: within the weekly dosing interval
Percentage of subjects experiencing adverse events
Time frame: from week 1 to end of trial at maximum 23 weeks
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