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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04710017
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Study Description
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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).


Condition or disease Intervention/treatment Phase
Uterine Bleeding Drug: Tranexamic acid Drug: Medroxyprogesterone Acetate 150 MG/ML Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
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.
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of bleeding days [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710017


Locations
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Egypt
Women Health Hospital - Assiut university Recruiting
Assiut, Egypt, 71111
Contact: Mohammed K ALi, MD    +201005537951    m_khairy2001@yahoo.com   
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Mohammed Khairy Ali, Assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT04710017    
Other Study ID Numbers: TA-DMPA
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Medroxyprogesterone Acetate
Tranexamic Acid
Medroxyprogesterone
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
 Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents