drugset / Trial / NCT04710017

Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding

NCT04710017

Completed 110 enrolled Assiut University
RandomizedParallel-groupOpen-labelTreatment

Summary

Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group. Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy. Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer. According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).

Timeline

Start
2021-02-01
Primary completion
2022-02-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 500 mg
Subject medroxyprogesterone acetate Other / unclassified 150 mg Intramuscular

Indications