The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
4X100 mg per oral, twice daily for 28 days
Once daily with (21) or without (28) pause for bleeding.
4X100 mg per oral, twice daily for 28 days
Research Site
Luleå, Sweden
Research Site
Uppsala, Sweden
Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Time frame: PK sampling will be performed regularly during the study period of two months.
Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2
Time frame: PD sampling will be done at the end of treatment period 1 and 2.
Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations
Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured.
Time frame: PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.
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