ISRCTN52706881已完成不适用
Double-blind, placebo-controlled, randomised, cross-over study to evaluate the interacting influence of 160 mg Silexan (WS®1265) on pharmacokinetics, and hormonal and ovarian activity in 24 healthy females taking an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 24 人开始时间: 2009年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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