NCT03531437终止4 期
Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 112
- 主要终点
- D-dimer
研究概览
简要总结
The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles
详细描述
compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman age 19-40 yr
- •Normal uterus and both adnexae
- •BMI < 28.5 kg/m2
- •Require contraception with COCs
排除标准
- •Pregnancy
- •Postartum period within 6 wk
- •BP ≥ 140/90 mmHg
- •Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
- •use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system
- •Use contraceptive steroids within 3 months
研究组 & 干预措施
Zoely
Active Comparator
Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles
干预措施: 1.5 mg estradiol and 2.5 mg nomegestrol acetate (Drug)
Minidoz
Active Comparator
Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles
干预措施: 15 µg ethinylestradiol and 60 µg gestodene (Drug)
结局指标
主要结局
D-dimer
时间窗: 12 weeks
µg/L
次要结局
- fibrinogen(12 weeks)
- antithrombin III(12 weeks)
- to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®(12 weeks)
研究者
Nalinee Panichyawat
Siriraj hospital
Mahidol University
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