Comparing Tranexamic Acid and Estrogen for Abnormal Uterine Bleeding in DMPA Users
Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
This study is testing whether Tranexamic Acid or Estrogen is better at helping women with abnormal bleeding after using a birth control shot called DMPA.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Department of Medical Services Ministry of Public Health of Thailand Government |
| Locations | 2 sites (Bangkok, Ratchathewi and 1 other locations) |
| Trial ID | NCT06067217 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to address abnormal uterine bleeding (AUB) in women using Depot Medroxyprogesterone Acetate (DMPA) by comparing the effectiveness of Tranexamic Acid and Estrogen. The study will administer Tranexamic Acid 250 mg and Progynova 1 mg to participants experiencing prolonged AUB after their first DMPA injection. The goal is to find a treatment that minimizes side effects while effectively managing bleeding. This research is particularly relevant in Thailand, where AUB is a leading cause of DMPA discontinuation.
Who should consider this trial
Good fit: Ideal candidates are women experiencing abnormal uterine bleeding for more than 7 days after their first DMPA injection who can provide informed consent and understand Thai.
Not a fit: Patients with contraindications to Tranexamic Acid or Estrogen, such as those with hypertension, stroke, or certain cancers, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for women suffering from abnormal uterine bleeding related to DMPA use.
How similar studies have performed: While there is limited data on similar studies, the approach of using Tranexamic Acid and Estrogen for AUB management in DMPA users is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok, Ratchathewi and 1 other locations
- Krittiporn Mahachiraphat — Bangkok, Ratchathewi, Thailand (Recruiting)
- Krittiporn Mahachiraphat, M.D. — Phaya Thai, Ratchathewi, Thailand (Not_yet_recruiting)
Study contacts
- Study coordinator: Krittiporn Mahachiraphat, M.D.
- Email: qqq_ruttew@live.com
- Phone: 0877996647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.