Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial

Conditions
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Abnormal Uterine Bleeding, Tranexamic Acid, Estrogen, Depot Medroxyprogesterone Acetate

Intervention / Treatment
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* Drug: Tranexamic acid 250 mg oral tablet
* Drug: Progynova 1 mg oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abnormal uterine bleeding more than 7 days after first DMPA injection Provide inform consent with patient Can understand thai language Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Tranexamic acid 250 mg oral three times/day | Drug: Tranexamic acid 250 mg oral tablet<br>* Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users<br>|
| Experimental: Progynova<br>Progynova 1 mg oral three times/day | Drug: Progynova 1 mg oral tablet<br>* Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect after receiving Tranexamic acid | To study side effect after receiving Tranexamic acid | 1 week after intervention | 
| Side effect after receiving estrogen | To study side effect after receiving estrogen | 1 week after intervention | 
| Frequency of bleeding after DMPA injection | To study frequency of bleeding after DMPA injection | after DMPA injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AUB, DMPA, Tranexamic acid, Estrogen