Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

NCT04290013 | Unknown Phase 3

• 1 other identifier: Protocol 400
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• endometrial thickness in centimetre.

  Before the intervention and 3 months afterwards

• endometrial volume in cubic centimetre.

  Before the intervention and 3 months afterwards

• uterine artery Doppler indices.

  Before the intervention and 3 months afterwards

• endometrial three-dimensional vascular indices.

  Before the intervention and 3 months afterwards

Study Arms (2)

norethisterone -women with Dysfunctional uterine bleeding

EXPERIMENTAL

Drug: norethisterone acetate

tranexemic acid-women with Dysfunctional uterine bleeding

EXPERIMENTAL

Drug: tranexamic acid tablets

Interventions

norethisterone acetate DRUG

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

norethisterone -women with Dysfunctional uterine bleeding

tranexamic acid tablets DRUG

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.

tranexemic acid-women with Dysfunctional uterine bleeding

Eligibility Criteria

• Age: 35 Years - 49 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Metrorrhagia

Interventions

Norethindrone Acetate; Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Eman Elkattan, MD,MRCOG,DFSRH

CONTACT

01212529213; emyelkattan@gmail.com

Yasser Khamis, MD

CONTACT

01125527555

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 28, 2020
• Study Start: April 22, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03