Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

Dysfunctional Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04290013
• Other study ID #: Protocol 400
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 22, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: Eman Elkattan, MD,MRCOG,DFSRH
• Phone: 01212529213
• Email: emyelkattan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Hemorrhage
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Drug:
• norethisterone acetate
norethisterone acetate 15 mg daily from day 5 of the cycle to day 26.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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