Abnormal Uterine Bleeding, Depot Medroxyprogesterone Acetate, Estrogen, Tranexamic Acid
Conditions
Keywords
AUB, DMPA, Tranexamic acid, Estrogen
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
Interventions
DRUGTranexamic acid 250 mg oral tablet
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
DRUGProgynova 1 mg oral tablet
Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Drug in concealed envelop which participant and care provider aren't see
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Contacts
Primary ContactKrittiporn Mahachiraphat, M.D.
Backup ContactSitanan Lertsiripanich, M.D.
Outcome results
None listed