NCT01324505已完成1 期
An Open-label, One-sequence Cross-over, Single Centre Trial Investigating the Influence of Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug After Multiple Dose Administration of Semaglutide in Subjects With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Area under the ethinylestradiol concentration-time curve
研究概览
简要总结
This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained by a physician before any trial-related activities
- •Postmenopausal women: a. With at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) above 40 mIU/mL and oestrogen deficiency (estradiol levels less than 30 pg/mL, or a negative gestagen test) or b. Bilateral oophorectomy (surgical removal of both ovaries)
- •Type 2 diabetes treated with either diet and exercise alone or with metformin (monotherapy) having a glycosylated haemoglobin (HbA1c) of 6.5 -10% (both inclusive)
- •Stable treatment of diabetes, either diet and exercise only or a stable dose level of metformin, for at least 3 months
- •BMI (Body Mass Index) between 18.5 - 35.0 kg/m^2 (both inclusive)
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial. Participation is defined as being dosed with either drug
- •Treatment with antidiabetic drug other than metformin within the last 3 months
- •Use of hormone replacement therapy within 4 weeks prior to starting dosing with the trial product
- •Presence or history of cancer or any clinically significant diseases or disorders, considered by the physician to have influence on the results of this trial
- •Subjects who are known to have hepatitis
- •Positive human immunodeficiency virus (HIV) antibodies
- •Uncontrolled treated/untreated hypertension (systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg)
- •History of alcoholism or drug abuse during the last 3 months
- •History of chronic or idiopathic acute pancreatitis
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
- •Subjects who are considered at increased risk of thrombosis formation, such as deep vein thrombosis, pulmonary embolism, infarction or apoplexy (as judged by the trial physician) and subjects who are smokers
- •Blood or plasma donation within the last 3 months prior to first dosing
- •Participation in any other trial investigating other products or involving blood sampling within the last 3 months prior to first dosing
- •Inability or unwillingness to perform self-injection (with placebo medium) at trial start
研究组 & 干预措施
One-sequence cross-over arm
Experimental
干预措施: semaglutide (Drug)
One-sequence cross-over arm
Experimental
干预措施: placebo (Drug)
One-sequence cross-over arm
Experimental
干预措施: Microgyn® (Drug)
结局指标
主要结局
Area under the ethinylestradiol concentration-time curve
时间窗: in the 24 hour dosing interval
Area under the levonorgestrel concentration-time curve
时间窗: in the 24 hour dosing interval
次要结局
- Maximum oral contraceptive concentration(in the 24 hour dosing interval)
- Area under the semaglutide concentration-time curve(in the 24 hour dosing interval)
- Maximum semaglutide concentration(within the weekly dosing interval)
- Percentage of subjects experiencing adverse events(from week 1 to end of trial at maximum 23 weeks)
研究者
研究点 (1)
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