NCT02845219已完成1 期
A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Area under the levonorgestrel plasma concentration-time curve during a dosing interval (0-24 hours) at steady state
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal female, age at least 45 years at the time of signing informed consent. With at least 12 consecutive months since the last spontaneous menstrual bleeding (if there was any uncertainty of the time of the last spontaneous bleeding, the postmenopausal status is to be confirmed with follicle stimulating hormone (FSH) 40 mIU/mL)
- •Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day). A subject smoking less than one cigarette or the equivalent per day must be able or willing to refrain from smoking and use of nicotine substitute products during the trial
- •Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
- •Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. If white-coat hypertension is suspected a single repeat measurement is allowed, last measurement being conclusive
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
研究组 & 干预措施
Oral contraceptive/SNAC/Oral Trial drug
Experimental
干预措施: semaglutide (Drug)
Oral contraceptive/SNAC/Oral Trial drug
Experimental
干预措施: SNAC (Drug)
Oral contraceptive/SNAC/Oral Trial drug
Experimental
干预措施: Microgynon® (Drug)
结局指标
主要结局
Area under the levonorgestrel plasma concentration-time curve during a dosing interval (0-24 hours) at steady state
时间窗: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)
Area under the ethinylestradiol plasma concentration-time curve during a dosing interval (0-24 hours) at steady state
时间窗: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)
次要结局
- Maximum observed ethinylestradiol plasma concentration during a dosing interval (0-24 hours) at steady state(On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state))
- Maximum observed levonorgestrel plasma concentration during a dosing interval 0-24 hours) at steady state(On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state))
研究者
研究点 (1)
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