Pharmacokinetics of ethinyl estradiol and levonorgestrel Not Applicable
Conditions
Interventions
One capsule with 160 mg Silexan or placebo respectively per day in the morning for 2 times 28 days (56 consecutive days).
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 38 years 2. Signed informed consent 3. Healthy female volunteer 4. Body mass index between 18 and 30 kg/m^2 5. At least 3 months since delivery, abortion, or lactation before randomisation 6. Willingness to use non-hormonal methods of contraception 7. Subjects must have taken oral contraceptive for at least two cycles before start of the first treatment cycle
Exclusion criteria
Exclusion criteria: 1. Pregnancy, a repeatedly positive urine pregnancy test or lactation 2. Known or suspected malign tumours or history thereof 3. Thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction) or other conditions that increase susceptibility to thromboembolic diseases 4. Known or suspected benign tumours of the liver, pituitary and adrenal gland or history thereof 5. Known or suspected liver disorders, diabetes mellitus, pancreatitis or a history thereof if associated with severe hypertriglycidemia or disturbances of lipid metabolism, kidney disease with impaired renal function 6. Gastrointestinal disorders with uncertain absorption of orally administered drugs 7. Known allergy to lavender oil or other ingredients of the investigational drug 8. History of migraine with neurological symptoms 9. Clinically significant depression (current or during the last year) 10. Any known diseases or conditions that compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication 11. Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results 12. Clinically relevant deviations from screened laboratory parameters 13. Sickle-cell anaemia 14. Epilepsy 15. Alcohol, drug, or medicine abuse or suspicion thereof 16. Donation of blood or plasmapheresis after signing the informed consent 17. Regular intake of the following medication: 17.1. Any drugs that might interfere with the study objectives especially any drugs known to induce liver enzymes 17.2. Any drugs known to inhibit CYP3A4 17.3. Any broad-spectrum antibiotics, long-acting injectable or implant hormonal therapy within 26 weeks prior to the screening phase 17.4. Any continuous combined oral contraceptive (COC) intake regimen after screening
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Hoogland score assessments at day 28 of the cycle 2. Cmax and tmax of levonorgestrel and ethinyl estradiol profiles, assessed over 24 hours at day 19, 20 or 21 of the cycle 3. Safety and tolerability | — |
Primary
| Measure | Time frame |
|---|---|
| Plasma levonorgestrel and ethinyl estradiol: AUCtau, at the PK profile days over 24 hours at day 19, 20 or 21 of the cycle. | — |
Countries
Germany
Outcome results
None listed