NCT02943655已完成3 期
Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- the amount of menstrual blood loss
研究概览
简要总结
Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.
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
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.
排除标准
- •Postmenopausal bleeding (over one year since the last menstrual period).
- •Irregular menses or intermenstrual bleeding.
- •Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
- •Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g. non-progestogen-releasing intrauterine contraceptive device, oral contraceptives, other hormonal drug use or anticoagulant agent).
- •Iron deficiency anemia.
- •History of chronic diseases known to interfere with menstrual bleeding or prevent the use of any of the listed drugs e.g previous or current thromboembolic disease.
研究组 & 干预措施
combined oral contraceptives
Active Comparator
oral second generation pills one tablet daily
干预措施: combined contraceptive pills (microcept) (Drug)
medroxyprogesterone acetate
Active Comparator
oral 5 mg daily
干预措施: medroxyprogesterone acetate (progest) (Drug)
non-steroidal anti-inflammatory
Active Comparator
oral 500 mg mefenamic acid three times per day
干预措施: mefenamic acid (ponstan forte) (Drug)
结局指标
主要结局
the amount of menstrual blood loss
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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