This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®. The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase each month. At 8 specific timepoints during Period 2, participants also get 1 tablet of Microgynon®. Participants visit the study site up to 40 times. At 8 visits, participants take Microgynon® and stay overnight at the site. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of ethinylestradiol and levonorgestrel in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
BI 456906
Ethinylestradiol (EE) and Levonorgestrel (LNG)
Charité Research Organisation GmbH
Berlin, Germany
Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to Week 29
Maximum measured concentration of ethinylestradiol in plasma (Cmax)
Time frame: up to Week 29
Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to Week 29
Maximum measured concentration of levonorgestrel in plasma (Cmax)
Time frame: up to Week 29
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