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

Rajavithi Hospital

Status: Enrolling

Conditions: Estrogen; Tranexamic Acid; Abnormal Uterine Bleeding; Depot Medroxyprogesterone Acetate

Treatments: Drug: Progynova 1 mg oral tablet; Drug: Tranexamic acid 250 mg oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06067217

166/2566

Details and patient eligibility

About

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

Full 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

Enrollment: 52 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

52 participants in 2 patient groups

Tranexamic acid

Experimental group

Description:

Tranexamic acid 250 mg oral three times/day

Treatment:

Drug: Tranexamic acid 250 mg oral tablet

Progynova

Experimental group

Description:

Progynova 1 mg oral three times/day

Treatment:

Drug: Progynova 1 mg oral tablet