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

Not Applicable

Completed

• Conditions: Uterine Bleeding
• Interventions: Drug: Tranexamic acid; Drug: Medroxyprogesterone Acetate 150 MG/ML

• Registration Number: NCT04710017
• Lead Sponsor: Assiut University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-05-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid group	Tranexamic acid	will tranexamic acid 500 mg 4 times daily in one group,
Medroxyprogesterone acetate	Medroxyprogesterone Acetate 150 MG/ML	will receive 150mg of medroxyprogesterone acetate once intramuscular.

Primary Outcome Measures

Name	Time	Method
Number of bleeding days	6 months

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt