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

NCT ID: NCT06067217

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-08-30

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

Conditions

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Abnormal Uterine Bleeding Tranexamic Acid Estrogen Depot Medroxyprogesterone Acetate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

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

Study Groups

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Tranexamic acid

Tranexamic acid 250 mg oral three times/day

Group Type EXPERIMENTAL

Tranexamic acid 250 mg oral tablet

Intervention Type DRUG

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Progynova

Progynova 1 mg oral three times/day

Group Type EXPERIMENTAL

Progynova 1 mg oral tablet

Intervention Type DRUG

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Interventions

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Tranexamic acid 250 mg oral tablet

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Intervention Type DRUG

Progynova 1 mg oral tablet

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Krittiporn Mahachiraphat

Bangkok, Ratchathewi, Thailand

Site Status RECRUITING

Krittiporn Mahachiraphat, M.D.

Phaya Thai, Ratchathewi, Thailand

Site Status NOT_YET_RECRUITING

Countries

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Thailand

Central Contacts

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Krittiporn Mahachiraphat, M.D.

Role: CONTACT

0877996647

Sitanan Lertsiripanich, M.D.

Role: CONTACT

0829727222

Facility Contacts

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Krittiporn Mahachiraphat, M.D.

Role: primary

0877996647

Sitanan Lertsiripanich, M.D.

Role: backup

0829727222

Krittiporn Mahachiraphat, M.D.

Role: primary

0877996647

Sitanan Lertsiripanich, M.D.

Role: backup

0829727222

Other Identifiers

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166/2566

Identifier Type: -

Identifier Source: org_study_id

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