Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subject
- •Age: 18 to 45 years (inclusive) at the first screening examination / visit
- •Body mass index (BMI): above or equal 18 and below or equal 30 kg / m²
- •At least 3 months since delivery, abortion, or lactation before the first screening examination / visit
排除标准
- •- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Liver diseases, kidney diseases, metabolic disorders, thyroid disorders and known or suspected malignant or benign tumors
- •Presence or a history of venous or arterial thrombotic/thromboembolic events
- •Migraine with neurologic symptoms (complicated migraine)
- •Clinically significant depression
- •Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them
研究组 & 干预措施
Arm 1
Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days
干预措施: Microgynon (Drug)
Arm 2
Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat
干预措施: Noristerat(BAY86-6308) (Drug)
结局指标
主要结局
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
时间窗: 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
时间窗: At different time points on day 21
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
时间窗: At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
时间窗: At different time points up to 8 weeks
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
时间窗: At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
时间窗: At different time points up to 8 weeks
次要结局
未报告次要终点