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

January 1, 2025 updated by: Bazgha Naeem, University of Health Sciences Lahore

Efficacy of Calcium Dobesilate As an Alternative Method for Treatment of Menorrhagia, Comparison to Tranexamic Acid

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial aims to compare the efficacy and safety of calcium dobesilate and tranexamic acid in treating menorrhagia in women aged 18 to 39 years. Menorrhagia, characterized by heavy menstrual bleeding exceeding 80 mL per cycle, significantly impacts quality of life and may lead to complications such as anemia.

Participants meeting the inclusion criteria will be randomly assigned to one of two groups:

Group A: Participants will receive calcium dobesilate (500 mg capsules), administered orally at a daily dose of 0.5-2 g during each menstrual cycle for three consecutive cycles.

Group B: Participants will receive tranexamic acid (500 mg capsules), administered orally at a dose of two capsules three times daily during each menstrual cycle for three consecutive cycles.

Primary outcomes will include:

Reduction in menstrual blood loss as measured by the Pictorial Blood Loss Assessment Chart (PBAC).

Improvement in hemoglobin levels after three cycles. Arrest of bleeding after discontinuation of the medications. Secondary outcomes will focus on the acceptability of treatment and side effects, such as nausea, headache, and gastrointestinal discomfort.

Data will be collected through patient records, physical examinations, and follow-up visits. Stratification and statistical analyses will be conducted using SPSS to evaluate differences in efficacy and safety between the two groups. The results will contribute to identifying a suitable treatment option for managing menorrhagia in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients age 18 to 39 years
  2. Patients with menorrhagia
  3. Incidence of breakthrough bleeding while on treatment
  4. Patient with heaviness of the bleeding

Exclusion Criteria:

  1. Patients with hemoglobin less than 7gm/dl
  2. Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus/cervix/ovary/vagina/endometrial hyperplasia with atypia.
  3. Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo/hyperthyroidism, platelet disorders or coagulopathy.
  4. 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

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
Active Comparator: Group A: Patients receiving Calcium Dobesilate (Doxium)

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)
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.
Active Comparator: Group B: Patients receiving Tranexamic Acid
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Menstrual Blood Loss
Time Frame: At the end of the third treatment cycle (each cycle is 28 days).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Hemoglobin Levels
Time Frame: At the end of the third treatment cycle (each cycle is 28 days).
Hemoglobin levels will be measured through venous blood samples using standard laboratory methods. Baseline levels will be recorded prior to treatment, and follow-up levels will be assessed at the end of the third treatment cycle (each cycle lasting 28 days). An increase in hemoglobin levels will indicate improved iron status and reduced anemia severity.
At the end of the third treatment cycle (each cycle is 28 days).

Collaborators and Investigators

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

Sponsor

University of Health Sciences Lahore

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 (Estimated)

January 5, 2025

Primary Completion (Estimated)

November 5, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 21, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp127

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

product manufactured in and exported from the U.S.

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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