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

NCT04710017 | Completed

• 1 other identifier: TA-DMPA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of bleeding days

  6 months

Study Arms (2)

Tranexamic acid group

OTHER

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

Drug: Tranexamic acid

Medroxyprogesterone acetate

OTHER

will receive 150mg of medroxyprogesterone acetate once intramuscular.

Drug: Medroxyprogesterone Acetate 150 MG/ML

Interventions

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.

Tranexamic acid group

Medroxyprogesterone Acetate 150 MG/ML DRUG

will be given MPA at 150 mg once intramuscular injection

Medroxyprogesterone acetate

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Tranexamic Acid; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)