Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

• Status: Not yet recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Norethindrone; Norethindrone Acetate; Tranexamic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.