Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Flow-mediated dilatation (FMD)
研究概览
简要总结
The goals of this clinical trial are to investigate the effect of the estetrol (E4)-drospirenone combined oral contraceptive (COC) pill on flow-mediated dilatation (FMD) of the brachial artery and pulse wave velocity (PWV), in comparison to the ethinylestradiol (EE)-levonorgestrel COC pill, and to compare their respective effects on blood pressure, chronic inflammatory markers, as well as glycaemic and lipid indices.
The main questions it aims to answer are:
Does E4-drospirenone COC have significantly smaller effects then EE-levonorgestrel COC on FMD, PWV, blood pressure, chronic inflammatory markers, as well as glycemic and lipid indices.
Researchers will compare E4-drospirenone to EE-levonorgestrel to see if the former has lower arterial vascular and metabolic risks.
Participants will:
- be randomised to take E4-drospirenone or EE-levonorgestrel COC pill according to product insert;
- visit the clinic at baseline and 6 and 12 months post-recruitment for checkups and tests
详细描述
Objectives: (1) To investigate the effect of the estetrol (E4)-drospirenone combined oral contraceptive (COC) pill on flow-mediated dilatation (FMD) of the brachial artery and pulse wave velocity (PWV), in comparison to the ethinyl-estradiol (EE)- levonorgestrel COC pill. (2) To investigate the effect of the E4-drospirenone COC pill on blood pressure, chronic inflammatory markers, as well as glycaemic /lipid indices.
Hypothesis to be tested: E4-drospirenone has non-significant effect on FMD and PWV, as well as on blood pressure, chronic inflammatory markers, glycaemic and lipid profile compared to EE-levonorgestrel.
Design and subjects: Open-label randomised controlled trial. Women (n=98) who are commencing COC pills for contraception or treatment of gynaecological conditions will be recruited.
Study instruments: FMD, carotid-femoral and brachial-ankle PWV, blood pressure, serum high-sensitivity C-reactive protein and interleukin-6 measurements, glycaemic and lipid profile
Interventions: (1) E4 15mg + drospirenone 3mg versus (2) EE 30mcg + levonorgestrel 150mcg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 49 years inclusive
- •Considering to use the COC pill for contraception or treatment of menstrual disorders
排除标准
- •Being diagnosed with menopause
- •Having contraindications to COC, including (but not confined to) hypertension, diabetes mellitus with complications, history of ischaemic heart disease, thromboembolism, stroke, severe liver disease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers aged 35 years or above, or having body mass index >=35 kg/m2
- •Planning to get pregnant in the coming 1 year
- •Having been pregnant in the past 3 months
- •Having been on COC or hormone replacement therapy in the past 3 months (those who had been on these agents can stop these for 3 months as wash-out period before being recruited; this concurs with other similar studies in the literature)
- •Having been on anti-hypertensive, anti-diabetic or lipid-lowering agents in the past 3 months
- •Refusal to randomization
研究组 & 干预措施
E4-drospirenone
Estetrol-drospirenone
干预措施: Estetrol-drospirenone (Drug)
EE-levonorgestrel
Ethinylestradiol-levonorgestrel
干预措施: Ethinylestradiol-levonorgestrel (Drug)
结局指标
主要结局
Flow-mediated dilatation (FMD)
时间窗: 0, 6 and 12 months
Flow-mediated dilatation of the brachial artery
次要结局
- Pulse wave velocity (PWV)(0, 6 and 12 months)
- Body mass index(0, 6 and 12 months)
- Waist-hip ratio(0, 6 and 12 months)
- Blood pressure(0, 6 and 12 months)
- Sex hormone-binding globulin(0, 6 and 12 months)
- High sensitivity C-reactive protein(0, 6 and 12 months)
- Fasting glucose(0, 6 and 12 months)
- 2-hour glucose(0, 6 and 12 months)
- Haemoglobin A1c(0, 6 and 12 months)
- Fasting insulin(0, 6 and 12 months)
- Lipid profile(0, 6 and 12 months)
研究者
Dr. Hang Wun Raymond Li
Clinical Associate Professor
The University of Hong Kong