Effect of Tranexemic Acid and Norethisterone Acetate on Endometrial Vasculature in Women With Dysfunctional Uterine Bleeding.
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 主要终点
- reducion of the menstrual flow.
研究概览
简要总结
Heavy periods is a significant problem in reproductive age .It affects about a third of women in the childbearing period
Any of the following is considered to be heavy menstrual bleeding (Bleeding that lasts more than 7 days,Bleeding that soaks through one or more tampons or pads every hour for several hours in a row.Needing to wear more than one pad at a time to control menstrual flow.,Needing to change pads or tampons during the night or Menstrual flow with blood clots that are as big as a quarter or larger) .
Heavy periods can be caused by organic cause as fibroids, adenomyosis, polyps or they can be dysfunctional.Dysfunctional uterine bleeding is irregular uterine bleeding that occurs in the absence of recognisable pelvic pathology, general medical disease, or pregnancy. It reflects a disruption in the normal cyclic pattern of ovulatory hormonal stimulation to the endometrial lining.
Several treatment options include: hormonal treatment as norethisterone acetate,oral contraceptive pills, gonadotrophin releasing hormone analogue. ,tranexamic acid or non steroidal anti-inflammatory drugs.
The investigators plan to do a comparative study between norethisterone acetate and tranexamic acid regarding their control of the heavy periods as well as their effect on the uterine and endometrial vasculature.
详细描述
This is a Randomised controlled trial.The investigators will randomise 120 women who suffer from heavy periods (age range 35-49 years old) without organic cause (Dysfunctional bleeding ) into 2 groups, group A (60 women) : They will take norethisterone acetate 15 mg daily from day 5 to day 26 of the period for 3 months.
Group B (60 women): They will take 1 gm tranexemic acid three times daily from the start of menstrual period up to 5 days.The dose might be increased per day (Not more than 4 gm per day).
The investigators will check endometrial thickness, endometrial volume, uterine artery Doppler indices as well as endometrial and subendometrial indices before starting the treatment and 3 months afterwards.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 35-49 years old.
- •Normal gynecologic and breast examination
- •Women who have sterilization or husband is sterilized or accepts to use a suitable barrier contraception during the duration of the study.
- •Heavy periods (were assessed by validated pictorial blood chart)
- •Normal ultrasound, hysteroscopy and endometrial biopsy.
- •Normal coagulation profile and thyroid function.
- •No contraindication to tranexamic acid or Norethisterone acetate : allergy,History of arterial or venous thromboembolic disease,Disturbance of liver function or Severe renal impairment.
排除标准
- •Women who are less than 35 years old or more than 49 years old.
- •Women who had organic cause for heavy periods as uterine polypi,fibroids or endometriosis.
- •Women taking hormonal preparation the month before starting the trial.
- •Women with abnormal findings in pelvic ultrasound,hysteroscopy or endometrial biopsy.
- •Women who suffer from uncontrolled diabetes or uncontrolled hypertension.
- •Women with history of breast cancer or precancerous conditions.
研究组 & 干预措施
norethisterone -women with Dysfunctional uterine bleeding
干预措施: norethisterone acetate (Drug)
tranexemic acid-women with Dysfunctional uterine bleeding
干预措施: tranexamic acid tablets (Drug)
结局指标
主要结局
reducion of the menstrual flow.
时间窗: 3 months
Using Pictorial Blood loss assessment chart depends on counting the sanitary pads and scoring the amount of blood in them)
次要结局
- endometrial thickness in centimetre.(Before the intervention and 3 months afterwards)
- endometrial three-dimensional vascular indices.(Before the intervention and 3 months afterwards)
- endometrial volume in cubic centimetre.(Before the intervention and 3 months afterwards)
- uterine artery Doppler indices.(Before the intervention and 3 months afterwards)
研究者
Eman Elkattan
Associate Professor
Cairo University