Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.
Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •sexually active women who did not wish to become pregnant,
- •aged between 18 and 35,
- •with menstrual cycles lasting between 24 and 32 days,
- •body mass index (BMI) between 18.0 and 29.9 kg/m2
排除标准
- •use of drugs and/or alcohol,
- •clinical and/or laboratory signs of hyperandrogenism,
- •use of hormonal contraception within six months before the initiation of the study,
- •presence of chronic and/or acute inflammatory processes,
- •use of medications with endothelial effects (e.g., statins),
- •breastfeeding or having stopped breastfeeding within two months before the initiation of the study,
- •medical conditions classified as category 3 or 4 according to the WHO medical eligibility criteria for contraceptive prescription
研究组 & 干预措施
30EE+DRSP
Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months
干预措施: 30EE+DRSP (Drug)
20EE+DRSP
Combined oral contraceptive containing 20 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months
干预措施: 20EE+DRSP (Drug)
结局指标
主要结局
Blood pressure
时间窗: 24 hours
Twenty-four-hour mean systolic blood pressure (SBP), 24-hour mean diastolic blood pressure (DBP), and day and nighttime SBP and DBP were measured by ambulatory blood pressure monitoring
次要结局
未报告次要终点
研究者
Carolina Sales Vieira
Professor of Obstetrics and Gynecology
University of Sao Paulo