MenorrhagiaNCT06763094
Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding
A study testing Calcium dobesilate (Doxium) and Tranexamic Acid in people with Menorrhagia and Abnormal Uterine Bleeding, run by University of Health Sciences Lahore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Menorrhagia, Abnormal Uterine Bleeding
- What is being tested?
- Calcium dobesilate (Doxium) and Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 18 to 39 years
- Patients with menorrhagia
- Incidence of breakthrough bleeding while on treatment
- Patient with heaviness of the bleeding
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Menorrhagia, Abnormal Uterine Bleeding
- Being tested
- Calcium dobesilate (Doxium), Tranexamic Acid
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Tranexamic AcidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of the third treatment cycle (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start5 Jan 2025 (estimated)
- Primary completion5 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bazgha Naeem, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763094
- Sponsor's protocol ID
- Exp127
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Calcium Dobesilate As an Alternative Method for Treatment of Menorrhagia, Comparison to Tranexamic Acid
- ClinicalTrials.gov ID
- NCT06763094
- Acronym / sponsor ID
- Exp127
- Conditions
- Menorrhagia, Abnormal Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients receiving Calcium Dobesilate (Doxium) | Active comparator | Drug: 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. |
| Group B: Patients receiving Tranexamic Acid | Active comparator | Drug: Tranexamic AcidIntervention: 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age 18 to 39 years
- Patients with menorrhagia
- Incidence of breakthrough bleeding while on treatment
- Patient with heaviness of the bleeding
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group A: Patients receiving Calcium Dobesilate (Doxium) |
| Tranexamic AcidTranexamic 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. | Drug | Group B: Patients receiving Tranexamic Acid |
Primary outcome
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.
1 secondary outcome
Improvement in Hemoglobin Levels
Time frame: At the end of the third treatment cycle (each cycle is 28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium dobesilate (Doxium) and Tranexamic Acid in people with Menorrhagia and Abnormal Uterine Bleeding, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bazgha Naeem, MS (OBSTETRICS & GYNAECOLOGY) (+923333522484, bazghatauqeer3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Menstrual Blood Loss (time frame: At the end of the third treatment cycle (each cycle is 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.