Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorUniversity of Health Sciences Lahore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age 18 to 39 years
Patients with menorrhagia
Incidence of breakthrough bleeding while on treatment
Patient with heaviness of the bleeding
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Calcium dobesilate (Doxium)
DrugThis 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.
Tranexamic Acid
DrugTranexamic 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group A: Patients receiving Calcium Dobesilate (Doxium)Active comparator 1 intervention
Group B: Group B: Patients receiving Tranexamic AcidActive comparator 1 intervention
Trial outcomes
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.
Time frame
At the end of the third treatment cycle (each cycle is 28 days).Secondary outcomes
1
Improvement in Hemoglobin Levels
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.
Time frame
At the end of the third treatment cycle (each cycle is 28 days).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: