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Completed

NCT Number: NCT04710017

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

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).

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Key information

Conditions

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

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
  • Patient's age ranging from 40- 55y.

Exclusion criteria

  • Post menopausal women
  • Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
  • Patients with uncontrolled hypertension.
  • Patient of abnormal bleeding profile.
  • history of liver impairment and renal insufficiency
  • Patients seeking for surgical management.

Treatment and study plan

Tranexamic Acid

Drug

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.

Medroxyprogesterone Acetate 150 MG/ML

Drug

will be given MPA at 150 mg once intramuscular injection

Primary outcomes

  1. Number of bleeding days

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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