Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin

NCT06707051 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 2096DHQTHS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.

Conditions

Heavy. Mentrual Bleeding; Abormal utèrine Bleeding; Bleeding; Uterine Bleeding; Hypersensitivity Response; GI Disturbance; Agranulocytosis; Bleeding Pattern; Endometrial; Endometrial Bleeding

Keywords

Tranexamic acid; Calcium Dobesilate; Bleeding of endometrial origin; TXA

Outcome Measures

Primary Outcomes (1)

• Reduction in blood loss

  Blood loss at baseline and three months after treatment will measured. Reduction in blood loss will be calculated after three months of treatment

  Three months

Study Arms (2)

Group A

EXPERIMENTAL

Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin

Drug: Tranexamic Acid

Group B

EXPERIMENTAL

Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin

Drug: Calcium dobesilate (Doxium)

Interventions

Tranexamic Acid DRUG

Group A received Trannexamic Acid 500mg three times a day for 5 days

Group A

Calcium dobesilate (Doxium) DRUG

Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days

Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of 18-40 years
• Abnormal uterine bleeding

You may not qualify if:

• Patients with pregnancy
• Miscarriage
• Hypersensitivity to pharmacological agents to be used in trial
• Patients having moderate to severe anemia (Hb:\<8gm/dl)
• Patients with thyroid abnormalities (TSH \> 5mIU)
• Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
• Uterine malignancy
• Coagulation disorders (PT : \>15sec).

Sponsors & Collaborators

• District Headquarters Teaching Hospital Sahiwal: lead

Study Sites (1)

Sahiwal teaching Hospital Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

Related Publications (4)

• Alaqzam TS, Stanley AC, Simpson PM, Flood VH, Menon S. Treatment Modalities in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2018 Oct;31(5):451-458. doi: 10.1016/j.jpag.2018.02.130. Epub 2018 Mar 8.

  PMID: 29524595 RESULT

• Klebanoff JS, Marfori CQ, Ingraham CF, Wu CZ, Moawad GN. Applications of Tranexamic acid in benign gynecology. Curr Opin Obstet Gynecol. 2019 Aug;31(4):235-239. doi: 10.1097/GCO.0000000000000547.

  PMID: 31022078 RESULT

• Franz ND, Machado-Aranda D, Miller JT, Farina N. Impact of Obesity on Tranexamic Acid Efficacy in Adult Patients With Major Bleeding. Ann Pharmacother. 2021 Sep;55(9):1076-1083. doi: 10.1177/1060028020983323. Epub 2020 Dec 31.

  PMID: 33384016 RESULT

• Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M. Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding. Cureus. 2021 Oct 29;13(10):e19122. doi: 10.7759/cureus.19122. eCollection 2021 Oct.

  PMID: 34858760 RESULT

MeSH Terms

Conditions

Hemorrhage; Uterine Hemorrhage; Agranulocytosis

Interventions

Tranexamic Acid; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 27, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)