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

NCT ID: NCT04710017

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-05-01

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).

Conditions

Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tranexamic acid group

will tranexamic acid 500 mg 4 times daily in one group,

Group Type: OTHER

Tranexamic acid

Intervention Type: 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

will receive 150mg of medroxyprogesterone acetate once intramuscular.

Group Type: OTHER

Medroxyprogesterone Acetate 150 MG/ML

Intervention Type: DRUG

will be given MPA at 150 mg once intramuscular injection

Interventions

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.

Intervention Type: DRUG

Medroxyprogesterone Acetate 150 MG/ML

will be given MPA at 150 mg once intramuscular injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

TA-DMPA

Identifier Type: -

Identifier Source: org_study_id