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

November 14, 2023 updated by: Rajavithi Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Ratchathewi
      • Bangkok, Ratchathewi, Thailand, 10400
        • Recruiting
        • Krittiporn Mahachiraphat
        • Contact:
        • Contact:
      • Phaya Thai, Ratchathewi, Thailand, 10400
        • Not yet recruiting
        • Krittiporn Mahachiraphat, M.D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 166/2566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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