Abnormal Uterine BleedingNCT06067217
Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users
A study testing Tranexamic acid 250 mg oral tablet and Progynova 1 mg oral tablet in people with Abnormal Uterine Bleeding and Tranexamic Acid, run by Department of Medical Services Ministry of Public Health of Thailand at 2 sites in Thailand.
Trial summary
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding, Tranexamic Acid, Estrogen
- What is being tested?
- Tranexamic acid 250 mg oral tablet and Progynova 1 mg oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesThailand
- Study dates
- 30 Sep 2023to 30 Aug 2024
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Abnormal uterine bleeding more than 7 days after first DMPA injection
- Provide inform consent with patient
- Can understand thai language
Who cannot join
- Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
- Have pathology in uterus from pelvic examination, pap smear and ultrasound
- Current pelvic infection
- Postpartum less than 6 months
- History deep vein thrombosis
- Breastfeeding
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Krittiporn Mahachiraphat
Bangkok, Ratchathewi, 10400
Krittiporn Mahachiraphat, M.D., 0877996647, qqq_ruttew@live.com
Sitanan Lertsiripanich, M.D., 0829727222, sitanan.lert@gmail.com
- Not yet recruiting
Krittiporn Mahachiraphat, M.D.
Phaya Thai, Ratchathewi, 10400
Krittiporn Mahachiraphat, M.D., 0877996647, qqq_ruttew@live.com
Sitanan Lertsiripanich, M.D., 0829727222, sitanan.lert@gmail.com
About this study
Official title: Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA
Read the detailed description
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect
- Being tested
- Tranexamic acid 250 mg oral tablet, Progynova 1 mg oral tablet
- Keywords
- AUB, DMPA, Tranexamic acid, Estrogen
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid 250 mg oral tabletDrug
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
Progynova 1 mg oral tabletDrug
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid 250 mg oral three times/day Receives: Drug: Tranexamic acid 250 mg oral tablet |
| Progynova | Experimental | Progynova 1 mg oral three times/day Receives: Drug: Progynova 1 mg oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
Measured: 1 week after intervention
Secondary outcomes (3)
Side effect after receiving Tranexamic acid
To study side effect after receiving Tranexamic acid
Measured: 1 week after intervention
Side effect after receiving estrogen
To study side effect after receiving estrogen
Measured: 1 week after intervention
Frequency of bleeding after DMPA injection
To study frequency of bleeding after DMPA injection
Measured: after DMPA injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start30 Sep 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067217
- Sponsor's protocol ID
- 166/2566
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06067217
- Acronym / sponsor ID
- 166/2566
- Keywords
- AUB, DMPA, Tranexamic acid, Estrogen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 4 Oct 2023 (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 the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA
Detailed description
Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acid 250 mg oral tabletTranexamic acid 250 mg oral three times/day |
| Progynova | Experimental | Drug: Progynova 1 mg oral tabletProgynova 1 mg oral three times/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Abnormal uterine bleeding more than 7 days after first DMPA injection
- Provide inform consent with patient
- Can understand thai language
Key exclusion criteria (6 listed)
- Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
- Have pathology in uterus from pelvic examination, pap smear and ultrasound
- Current pelvic infection
- Postpartum less than 6 months
- History deep vein thrombosis
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 acid 250 mg oral tabletCompare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users | Drug | Tranexamic acid |
| Progynova 1 mg oral tabletCompare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users | Drug | Progynova |
Primary outcome
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
Time frame: 1 week after intervention
To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
3 secondary outcomes
Side effect after receiving Tranexamic acid
Time frame: 1 week after intervention
Side effect after receiving estrogen
Time frame: 1 week after intervention
Frequency of bleeding after DMPA injection
Time frame: after DMPA injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid 250 mg oral tablet and Progynova 1 mg oral tablet in people with Abnormal Uterine Bleeding and Tranexamic Acid, run by Department of Medical Services Ministry of Public Health of Thailand at 2 sites in Thailand.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krittiporn Mahachiraphat, M.D. (0877996647, qqq_ruttew@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen (time frame: 1 week after intervention). 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 18 Nov 2023.