Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold Crossover Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 31
- 主要终点
- Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
研究概览
简要总结
Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 52 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subject
- •Non-smokers of at least 3 month before screening
- •Age: 52 to 65 years (inclusive) at the first screening examination
- •Ethnicity: white
- •Body mass index (BMI)>=20 and <=32 kg/m2
- •Postmenopausal state, defined as
- •Medical history, if applicable (natural menopause at least 12 months before the first study drug administration and hormone analyses in serum
- •Age<60 years: follicle-stimulating hormone (FSH) >40 IU/L in plasma
- •Age <60 years: estradiol (E2) <20 ng/L (<73 pmol/L) in plasma
排除标准
- •History of coronary artery disease, Symptomatic postural hypotension, History of bronchial asthma, known hypersensitivity to the study, relevant diseases within 4 weeks before study drug administration,
- •Presence or a history of venous or arterial thrombotic / thromboembolic events or cerebrovascular accident, a high risk for venous or arterial thrombosis,
- •Use of systemic or topical medicines or substances which oppose the study objectives, smoking, use of sex hormones in any forms
- •Clinically relevant findings in the ECG, systolic blood pressure below 110 or above 145 mmHg, heart rate below 50 or above 95 beats per minute
- •Clinically relevant findings in the gynecological examination,
- •Participation in another clinical study
研究组 & 干预措施
Arm1
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
干预措施: Microgynon (Drug)
Arm2
multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
干预措施: Microgynon (Drug)
Arm2
multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
干预措施: Riociguat (Adempas,BAY63-2521) (Drug)
结局指标
主要结局
Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
时间窗: Up to 4 months
Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
时间窗: Up to 4 months
Maximal concentration (Cmax) of Ethinylestradiol (EE)
时间窗: Up to 4 months
Maximal concentration (Cmax) of Levonorgestrel (LNG)
时间窗: Up to 4 months
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Up to 4 months)