The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Androgen secretion
研究概览
简要总结
The impact of different administration routes of hormonal contraceptives on androgen secretion, glucose metabolism and inflammation. A prospective randomized trial.
The investigators assume, that transdermal or transvaginal hormonal contraception would have less effects on androgen levels, glucose metabolism and inflammatory markers than oral contraceptives.
详细描述
45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35 years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9 weeks. The subjects should have at least 2 months wash out period from all hormonal medication prior to the study.
The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women aged from 20 to 35 years
- •regular menstruation
- •no use of hormonal contraception or two months wash-out period
- •no contraindications for using hormonal contraception
排除标准
- •irregular menstruation
- •alcohol addiction
- •pregnancy or nursing
- •hypersensitivity to any components of the products
- •headaches with focal neurological symptoms
- •serious or multiple risk factors for artery disease
- •undiagnosed abnormal genital bleeding
- •impaired glucose tolerance or DM-T2
研究组 & 干预措施
Oral contraceptive pill
9 weeks treatment with contraceptive pill.
干预措施: Desogestrel-Ethinyl Estradiol contraceptive pill (Drug)
Contraception vaginal ring
9 weeks treatment with vaginal ring.
干预措施: Etonogestrel-Ethinyl Estradiol vaginal ring (Drug)
Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.
干预措施: Norelgestromin-Ethinyl Estradiol contraceptive patch (Drug)
结局指标
主要结局
Androgen secretion
时间窗: 0, 5, 9, 10 weeks
Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
Protein secretion from liver
时间窗: 0, 5, 9, 10 weeks
Analysis of SHBG and high sensitivy CRP from fasting serum samples.
次要结局
- Glucose metabolism(0, (5), 9, (10) weeks)