Status:
UNKNOWN
Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .
Lead Sponsor:
Cairo University
Conditions:
Dysfunctional Uterine Bleeding
Eligibility:
FEMALE
35-49 years
Phase:
PHASE3
Brief 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 th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04290013
Start Date
April 22 2020
End Date
December 31 2020
Last Update
March 16 2020
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