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

Sponsor

Rajavithi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067217

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding Tranexamic Acid Estrogen Depot Medroxyprogesterone Acetate	Drug: Tranexamic acid 250 mg oral tablet Drug: Progynova 1 mg oral tablet	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Drug in concealed envelop which participant and care provider aren't see

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
Frequency of bleeding after DMPA injection [after DMPA injection]
To study frequency of bleeding after DMPA injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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