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

April 23, 2024 updated by: Mohammed Khairy Ali, Assiut University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tranexamic acid group
will tranexamic acid 500 mg 4 times daily in one group,
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.
Other: Medroxyprogesterone acetate
will receive 150mg of medroxyprogesterone acetate once intramuscular.
Drug: Medroxyprogesterone Acetate 150 MG/ML
will be given MPA at 150 mg once intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of bleeding days
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-DMPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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