NCT01254799已完成3 期
Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
Omar Mamdouh Shaaban1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Stoppage of bleeding within 7 days
研究概览
简要总结
This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women under DMPA contraception for at least one month.
- •Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients.
- •Women's ability to keep an accurate menstrual diary for the study.
排除标准
- •Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
- •Patients with already diagnosed local gynecological abnormality.
- •Women receiving treatment for bleeding within the last one month.
研究组 & 干预措施
Placebo
Placebo Comparator
Women in this arm will receive identical Placebo capsules twice daily for 5 days
干预措施: Placebo (Drug)
Doxycycline
Active Comparator
Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
干预措施: Doxycycline (Drug)
结局指标
主要结局
Stoppage of bleeding within 7 days
时间窗: 7 days from starting of tretment
次要结局
- Number of days needed to stop a current attack of bleeding(1 month)
- Next bleeding free interval(3 month)
- Uterine bleeding patterns in the next 3 months after treatment(3 months)
- Women satisfaction with the treatment she received(3 months)
- Side effects encountered during treatment(5 days)
- Discontinuation of the DMPA and its reason(3 months)
研究者
Omar Mamdouh Shaaban
Dr
Assiut University
研究点 (1)
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