NCT04710017

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

Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Uterine Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic acid	will be given Tranexamic acid at 500 mg four times daily (2 g/day) during the bleeding episodes for 5 days. The dose is 250 mg.
DRUG	Medroxyprogesterone Acetate 150 MG/ML	will be given MPA at 150 mg once intramuscular injection

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-02-01
• Completion: 2022-05-01
• First posted: 2021-01-14
• Last updated: 2024-04-24

Locations

1 site across 1 country: Egypt