Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

Effect of Tranexemic Acid and Norethisterone Acetate on Endometrial Vasculature in Women With Dysfunctional Uterine Bleeding.

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.

Study Overview

• Status: Unknown
• Conditions: Dysfunctional Uterine Bleeding
• Intervention / Treatment: Drug: norethisterone acetate; Drug: tranexamic acid tablets

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, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: norethisterone -women with Dysfunctional uterine bleeding	Drug: norethisterone acetate; norethisterone acetate 15 mg daily from day 5 of the cycle to day 26.
Experimental: tranexemic acid-women with Dysfunctional uterine bleeding	Drug: tranexamic acid tablets; tranexemic acid 1 gm three times daily from the first day of the menstrual cycle up to 5 days .The dose can be increased but not exceeding 4 gm per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reducion of the menstrual flow.	Using Pictorial Blood loss assessment chart depends on counting the sanitary pads and scoring the amount of blood in them)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness in centimetre.	Measurement of the thickest part of the endometrium in centimetres in the longitudinal plan of the uterus using Two- Dimensional Transvaginal ultrasound	Before the intervention and 3 months afterwards
endometrial volume in cubic centimetre.	Measurement of the endometrial volume in cubic centimetres using Three-Dimensional transvaginal ultrasound	Before the intervention and 3 months afterwards
uterine artery Doppler indices.	Measurement of the uterine artery Doppler indices using Transvaginal ultrasound and taking the mean for both arteries.	Before the intervention and 3 months afterwards
endometrial three-dimensional vascular indices.	Measuring the vascularity in the endometrium using power doppler and Three -Dimensional transvaginal ultrasound.	Before the intervention and 3 months afterwards

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 22, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Metrorrhagia; Uterine Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Tranexamic Acid; Norethindrone; Norethindrone Acetate
• Other Study ID Numbers: Protocol 400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No