Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Matsuda Index- Whole Body Insulin Sensitivity Index
研究概览
简要总结
The main objective of the study is to compare the metabolic effects of natural estradiol and synthetic ethinylestradiol used in combined oral contraception in healthy women. A progestin-only preparation will be used in comparison. The main goal is to study the effects on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels, markers of coagulation and chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception
排除标准
- •Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
研究组 & 干预措施
Synthetic estrogen + progestin
Ethinyl estradiol / dienogest
干预措施: Ethinyl estradiol / dienogest (Drug)
Natural estrogen + progestin
Estradiol valerate / dienogest
干预措施: Estradiol valerate / dienogest (Drug)
Progestin-Only
Dienogest
干预措施: Dienogest (Drug)
结局指标
主要结局
Matsuda Index- Whole Body Insulin Sensitivity Index
时间窗: We calculated the change in Matsuda index from baseline to 9 weeks.
Matsuda index is calculated from the standard 2h Oral Glucose Tolerance Test and corresponding insulin values. Matsuda index = 10,000/square root of \[fasting glucose x fasting insulin\] x \[mean glucose x mean insulin during OGTT\]) The Matsuda index is correlated (r = 0.73) with the rate of whole-body glucose disposal during the euglycemic insulin clamp. Matsuda index \<2.5 is considered insulin resistant, higher values indicate less insulin resistance. A decrease in matsuda index over the study period would indicate decreased insulin sensitivity.
次要结局
- Low-Density Lipoprotein (LDL)(baseline and 9 weeks)
- Triglyceride(baseline and 9 weeks)
- F1+2(baseline and 9 weeks)
- High-sensitivity C Reactive Protein(baseline and 9 weeks)
- Total Cholesterol(baseline and 9 weeks)
- D-dimer(baseline and 9 weeks)
- Fasting Insulin(baseline and 9 weeks)
- High-Density Lipoprotein (HDL)(baseline and 9 weeks)
- Thrombin Generation, ETP Endogenous Thrombin Potential(baseline and 9 weeks)
研究者
Annina Haverinen
MD
Helsinki University Central Hospital