Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding

NCT06763094 | Not Yet Recruiting

• 1 other identifier: Exp127
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to determine if calcium dobesilate is an effective alternative to tranexamic acid for treating menorrhagia in women aged 18 to 39 years. The main questions it aims to answer are: Does calcium dobesilate reduce menstrual blood loss and improve hemoglobin levels as effectively as tranexamic acid? What side effects and acceptability differences exist between calcium dobesilate and tranexamic acid? Researchers will compare calcium dobesilate to tranexamic acid to see if calcium dobesilate is as effective in reducing heavy menstrual bleeding and improving patient outcomes. Participants will: Take calcium dobesilate or tranexamic acid during their menstrual cycle for three consecutive cycles. Record menstrual blood loss using the Pictorial Blood Loss Assessment Chart (PBAC). Attend follow-up visits after each menstrual cycle to monitor hemoglobin levels, menstrual symptoms, and any side effects.

Conditions

Menorrhagia; Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• Reduction in Menstrual Blood Loss

  Menstrual blood loss will be measured using the Pictorial Blood Loss Assessment Chart (PBAC). Participants will record the number and type of sanitary products used (e.g., pads or tampons) and the degree of saturation, along with any clots passed. PBAC scores above 100 are indicative of heavy menstrual bleeding. A reduction in PBAC scores after the third treatment cycle (each cycle lasting 28 days) will be used to determine the effectiveness of the intervention.

  At the end of the third treatment cycle (each cycle is 28 days).

Secondary Outcomes (1)

• Improvement in Hemoglobin Levels

  At the end of the third treatment cycle (each cycle is 28 days).

Study Arms (2)

Group A: Patients receiving Calcium Dobesilate (Doxium)

ACTIVE COMPARATOR

Intervention: Patients in Group A will be administered Calcium Dobesilate (Doxium) capsules. Dosage: The dose will be 500 mg of Calcium Dobesilate, administered orally at a frequency of three times a day. The total daily dose can range from 1-4 tablets (equivalent to 0.5-2 g/day), starting from the first day of the menstrual cycle and continuing until the bleeding ceases.

Drug: Calcium dobesilate (Doxium)

Group B: Patients receiving Tranexamic Acid

ACTIVE COMPARATOR

Intervention: Patients in Group B will receive Tranexamic Acid capsules. Dosage: The dose will be 500 mg of Tranexamic Acid, administered orally at a frequency of three times a day. This will continue from the first day of the menstrual cycle until the bleeding stops.

Drug: Tranexamic Acid

Interventions

Calcium dobesilate (Doxium) DRUG

This intervention is unique because Calcium Dobesilate is not a hormonal agent and does not carry the risks associated with hormonal therapies, such as potential impact on fertility or long-term endocrine effects. Additionally, it may be more suitable for patients who cannot tolerate hormonal treatments due to contraindications such as previous thrombotic events or risk factors for thrombosis.

Group A: Patients receiving Calcium Dobesilate (Doxium)

Tranexamic Acid DRUG

Tranexamic Acid stands out due to its non-hormonal action in managing menorrhagia, providing an alternative for women who are contraindicated for hormonal treatments or prefer non-hormonal solutions. Unlike other hormonal treatments, Tranexamic Acid does not impact fertility or have significant endocrine effects.

Group B: Patients receiving Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age 18 to 39 years
• Patients with menorrhagia
• Incidence of breakthrough bleeding while on treatment
• Patient with heaviness of the bleeding

You may not qualify if:

• Patients with hemoglobin less than 7gm/dl
• Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus/cervix/ovary/vagina/endometrial hyperplasia with atypia.
• Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo/hyperthyroidism, platelet disorders or coagulopathy.
• Patient with previous history of thrombosis; pregnancy, abortion, use of IUCDs or oral contraceptives; lactating women in first 6 months of post-natal period and hypersensitivity to the drug

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Menorrhagia; Metrorrhagia

Interventions

Calcium Dobesilate; Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; 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; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Bazgha Naeem, MS (OBSTETRICS & GYNAECOLOGY)

CONTACT

+923333522484; bazghatauqeer3@gmail.com

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: Post Graduate Resident

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 8, 2025
• Study Start: January 5, 2025
• Primary Completion: November 5, 2025
• Study Completion: December 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01