The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.
Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.
Unnamed facility
Berlin, State of Berlin, Germany
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
Time frame: At different time points on day 21
Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
Time frame: At different time points on day 21
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
Time frame: At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
Time frame: At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks
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