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

NCT06763094 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-08

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-05
Primary Completion
2025-11-05
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763094 on ClinicalTrials.gov