Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of bleeding days
研究概览
简要总结
Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group.
Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy.
Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer.
According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).
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
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
- •Patient's age ranging from 40- 55y.
排除标准
- •Post menopausal women
- •Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
- •Patients with uncontrolled hypertension.
- •Patient of abnormal bleeding profile.
- •history of liver impairment and renal insufficiency
- •Patients seeking for surgical management.
研究组 & 干预措施
Tranexamic acid group
will tranexamic acid 500 mg 4 times daily in one group,
干预措施: Tranexamic acid (Drug)
Medroxyprogesterone acetate
will receive 150mg of medroxyprogesterone acetate once intramuscular.
干预措施: Medroxyprogesterone Acetate 150 MG/ML (Drug)
结局指标
主要结局
Number of bleeding days
时间窗: 6 months
次要结局
未报告次要终点
研究者
Mohammed Khairy Ali
Assistant professor
Assiut University