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

Not Applicable

Recruiting

• Conditions: Depot Medroxyprogesterone Acetate; Tranexamic Acid; Abnormal Uterine Bleeding; Estrogen
• Interventions: Drug: Tranexamic acid 250 mg oral tablet; Drug: Progynova 1 mg oral tablet

• Registration Number: NCT06067217
• Lead Sponsor: Rajavithi Hospital

Brief 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

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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-27
• Study Start: 2023-09-30
• Study First Posted: 2023-10-04
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic acid 250 mg oral tablet	Tranexamic acid 250 mg oral three times/day
Progynova	Progynova 1 mg oral tablet	Progynova 1 mg oral three times/day

Primary Outcome Measures

Name	Time	Method
Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen	1 week after intervention	To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen

Secondary Outcome Measures

Name	Time	Method
Frequency of bleeding after DMPA injection	after DMPA injection	To study frequency of bleeding after DMPA injection
Side effect after receiving Tranexamic acid	1 week after intervention	To study side effect after receiving Tranexamic acid
Side effect after receiving estrogen	1 week after intervention	To study side effect after receiving estrogen

Trial Locations

Locations (2)

Krittiporn Mahachiraphat, M.D.; 🇹🇭 Phaya Thai, Ratchathewi, Thailand

Krittiporn Mahachiraphat; 🇹🇭 Bangkok, Ratchathewi, Thailand