Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

Launched by CAIRO UNIVERSITY · Feb 26, 2020

Keywords

ClinConnect Summary

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 arter...

Gender

FEMALE

Eligibility 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.