Heavy. Mentrual BleedingPhase 2/3TXANCT06707051
Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin
A Phase 2/3 study testing Tranexamic Acid and Calcium dobesilate (Doxium) in people with Heavy. Mentrual Bleeding and Abormal utèrine Bleeding, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.
Trial summary
Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Heavy. Mentrual Bleeding, Abormal utèrine Bleeding, Bleeding
- What is being tested?
- Tranexamic Acid and Calcium dobesilate (Doxium)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 30 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of 18-40 years
- Abnormal uterine bleeding
Who cannot join
- Patients with pregnancy
- Miscarriage
- Hypersensitivity to pharmacological agents to be used in trial
- Patients having moderate to severe anemia (Hb:<8gm/dl)
- Patients with thyroid abnormalities (TSH > 5mIU)
- Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
- Uterine malignancy
- Coagulation disorders (PT : >15sec).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sahiwal teaching Hospital Sahiwal
Sahiwal, Punjab Province, 57000
About this study
Official title: Comparison of Efficacy of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin
Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.
Read the detailed description
This Randomized control trial was conducted at Obstetrics \& Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.
- Conditions
- Heavy. Mentrual Bleeding, Abormal utèrine Bleeding, Bleeding, Uterine Bleeding, Hypersensitivity Response, GI Disturbance
- Being tested
- Tranexamic Acid, Calcium dobesilate (Doxium)
- Keywords
- Tranexamic acid, Calcium Dobesilate, Bleeding of endometrial origin, TXA
- Medical subject headings
- Hemorrhage, Uterine Hemorrhage, Agranulocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Group A received Trannexamic Acid 500mg three times a day for 5 days
Calcium dobesilate (Doxium)Drug
Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin Receives: Drug: Tranexamic Acid |
| Group B | Experimental | Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin Receives: Drug: Calcium dobesilate (Doxium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in blood loss
Blood loss at baseline and three months after treatment will measured. Reduction in blood loss will be calculated after three months of treatment
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heavy. Mentrual BleedingStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- District Headquarters Teaching Hospital Sahiwal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahpara Shaukat, District Headquarters Teaching Hospital Sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707051
- Sponsor's protocol ID
- 2096
- Other IDs
- DHQTHS
- Acronym
- TXA
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Publications
Alaqzam TS, Stanley AC, Simpson PM, Flood VH, Menon S. Treatment Modalities in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2018 Oct;31(5):451-458. doi: 10.1016/j.jpag.2018.02.130. Epub 2018 Mar 8.
PubMed 29524595Klebanoff JS, Marfori CQ, Ingraham CF, Wu CZ, Moawad GN. Applications of Tranexamic acid in benign gynecology. Curr Opin Obstet Gynecol. 2019 Aug;31(4):235-239. doi: 10.1097/GCO.0000000000000547.
PubMed 31022078Franz ND, Machado-Aranda D, Miller JT, Farina N. Impact of Obesity on Tranexamic Acid Efficacy in Adult Patients With Major Bleeding. Ann Pharmacother. 2021 Sep;55(9):1076-1083. doi: 10.1177/1060028020983323. Epub 2020 Dec 31.
PubMed 33384016Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M. Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding. Cureus. 2021 Oct 29;13(10):e19122. doi: 10.7759/cureus.19122. eCollection 2021 Oct.
PubMed 34858760
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin
- ClinicalTrials.gov ID
- NCT06707051
- Acronym / sponsor ID
- TXA / 2096
- Conditions
- Heavy. Mentrual Bleeding, Abormal utèrine Bleeding, Bleeding, Uterine Bleeding, Hypersensitivity Response, GI Disturbance
- Keywords
- Tranexamic acid, Calcium Dobesilate, Bleeding of endometrial origin, TXA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- District Headquarters Teaching Hospital SahiwalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Nov 2024 (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.
Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.
Detailed description
This Randomized control trial was conducted at Obstetrics \& Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tranexamic AcidGroup A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin |
| Group B | Experimental | Drug: Calcium dobesilate (Doxium)Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women of 18-40 years
- Abnormal uterine bleeding
Key exclusion criteria (8 listed)
- Patients with pregnancy
- Miscarriage
- Hypersensitivity to pharmacological agents to be used in trial
- Patients having moderate to severe anemia (Hb:<8gm/dl)
- Patients with thyroid abnormalities (TSH > 5mIU)
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 |
|---|---|---|
| Tranexamic AcidGroup A received Trannexamic Acid 500mg three times a day for 5 days | Drug | Group A |
| Calcium dobesilate (Doxium)Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days | Drug | Group B |
Primary outcome
Reduction in blood loss
Time frame: Three months
Blood loss at baseline and three months after treatment will measured. Reduction in blood loss will be calculated after three months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Results publication: PubMed 29524595Alaqzam TS, Stanley AC, Simpson PM, Flood VH, Menon S. Treatment Modalities in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2018 Oct;31(5):451-458. doi: 10.1016/j.jpag.2018.02.130. Epub 2018 Mar 8.
- Results publication: PubMed 31022078Klebanoff JS, Marfori CQ, Ingraham CF, Wu CZ, Moawad GN. Applications of Tranexamic acid in benign gynecology. Curr Opin Obstet Gynecol. 2019 Aug;31(4):235-239. doi: 10.1097/GCO.0000000000000547.
- Results publication: PubMed 33384016Franz ND, Machado-Aranda D, Miller JT, Farina N. Impact of Obesity on Tranexamic Acid Efficacy in Adult Patients With Major Bleeding. Ann Pharmacother. 2021 Sep;55(9):1076-1083. doi: 10.1177/1060028020983323. Epub 2020 Dec 31.
- Results publication: PubMed 34858760Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M. Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding. Cureus. 2021 Oct 29;13(10):e19122. doi: 10.7759/cureus.19122. eCollection 2021 Oct.
- Individual participant dataSharing planned: No. Patient privacy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid and Calcium dobesilate (Doxium) in people with Heavy. Mentrual Bleeding and Abormal utèrine Bleeding, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in blood loss (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707051, which also lists 4 linked publications.
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 27 Nov 2024.