Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
研究概览
简要总结
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA
详细描述
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect
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)
盲法说明
Drug in concealed envelop which participant and care provider aren't see
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Abnormal uterine bleeding more than 7 days after first DMPA injection
- •Provide inform consent with patient
- •Can understand thai language
排除标准
- •Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
- •Have pathology in uterus from pelvic examination, pap smear and ultrasound
- •Current pelvic infection
- •Postpartum less than 6 months
- •History deep vein thrombosis
- •Breastfeeding
研究组 & 干预措施
Tranexamic acid
Tranexamic acid 250 mg oral three times/day
干预措施: Tranexamic acid 250 mg oral tablet (Drug)
Progynova
Progynova 1 mg oral three times/day
干预措施: Progynova 1 mg oral tablet (Drug)
结局指标
主要结局
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
时间窗: 1 week after intervention
To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
次要结局
- Frequency of bleeding after DMPA injection(after DMPA injection)
- Side effect after receiving Tranexamic acid(1 week after intervention)
- Side effect after receiving estrogen(1 week after intervention)