drugset / Trial / NCT04290013

Effects of Tranexemic Acid Versus Norethisterone Acetate on Endometrial Vasculature .

NCT04290013

Phase 3 Unknown 120 enrolled Cairo University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2020-04-22
Primary completion
2020-10-01
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Norethindrone Unknown 15 mg
Subject Tranexamic Acid Small molecule 1 g

Indications