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NCT06067217 Clinical Trial

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

Abnormal Uterine Bleeding Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06067217
Other study ID # 166/2566
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date August 30, 2024

Study information
Verified date August 2023
Source Rajavithi Hospital
Contact Krittiporn Mahachiraphat, M.D.
Phone 0877996647
Email qqq_ruttew@live.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 52
Est. completion date August 30, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic acid 250 mg oral tablet
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
• Progynova 1 mg oral tablet
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Locations
Country Name City State
Thailand Krittiporn Mahachiraphat Bangkok Ratchathewi
Thailand Krittiporn Mahachiraphat, M.D. Phaya Thai Ratchathewi

Sponsors (1)
Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Side effect after receiving Tranexamic acid To study side effect after receiving Tranexamic acid 1 week after intervention
Secondary Side effect after receiving estrogen To study side effect after receiving estrogen 1 week after intervention
Secondary Frequency of bleeding after DMPA injection To study frequency of bleeding after DMPA injection after DMPA injection
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