Unscheduled bleeding in women using etonogestrel contraceptive implantation Unscheduled bleeding Etonogestrel implantation
Conditions
Interventions
Estradiol 2 mg orally twice daily for 14 days.,Ethinyl estradiol 20 mcg plus desogestrel 0.15 mg orally once daily for 14 days.,Tranexamic acid 500 mg (two 250 mg tablets) orally twice daily for 5 day
Estrogen monotherapy,Combine oral contraception,Tranexamic acid
Sponsors
Faculty of medicine, Siriraj hospital, Mahidol university
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Females aged between 18 and 40 years. 2. Currently using an Etonogestrel subdermal contraceptive implant. 3. Have had the implant in place for at least 3 months, but not exceeding 36 months. 4. Experiencing abnormal vaginal bleeding for at least 7 days since the date of implantation, and the bleeding persists on the day of enrollment. 5. Seeking treatment for irregular bleeding associated with the contraceptive implant. 6. Capable of complying with all study procedures, including the accurate recording of bleeding diaries. 7. Able to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Severe abnormal vaginal bleeding affecting vital signs or requiring blood component transfusion. 2. Contraindications to medications containing Estrogen or Tranexamic acid, including: a. Contraindications according to WHO MEC Category 3 or 4. b. History of venous thromboembolism (VTE) or arterial thrombosis. c. History of breast cancer or other hormone-sensitive malignancies. d. Uncontrolled hypertension (SBP more than 140 mmHg or DBP more than 90 mmHg). e. Severe hepatic or renal impairment. 3. Known hypersensitivity or allergy to Estrogen, Progestin, or Tranexamic acid. 4. Presence or suspicion of organic/physical causes of abnormal bleeding, such as submucosal uterine fibroids (FIGO type 0-3), endometrial or cervical polyps, or cervicitis. 5. Currently pregnant (positive urine pregnancy test) or breastfeeding. 6. Current use of medications affecting blood coagulation or presence of underlying bleeding disorders. 7. Previous treatment for abnormal bleeding using hormonal therapy, Tranexamic acid, or NSAIDs within 30 days prior to enrollment. 8. Current use of known CYP3A4 enzyme inducers (e.g., anticonvulsants, Rifampicin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to bleeding cessation At the first of three consecutive days of no bleeding Patient reported outcome using a bleeding diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving complete cessation of bleeding within 7 days after starting treatment Within 3 month after end of the intervention Patient reported outcome using a bleeding diary,Duration of the bleeding-free interval Within 3 month after end of the intervention Patient reported outcome using a bleeding diary,Proportion of participants who remain bleeding-free from the completion of treatment until the end of the 3-month follow-up period. Within 3 month after end of the intervention Patient reported outcome using a bleeding diary,Recurrence rates of abnormal bleeding within 3 months following treatment Within 3 month after end of the intervention Patient reported outcome using a bleeding diary,Patterns and severity of bleeding recurrence after treatment Within 3 month after end of the intervention Patient reported outcome using a bleeding diary,Overall treatment satisfaction At the end of the 3-month follow-up Patient reported outcome using a Likert scale,Continuation rates of the contraceptive implantation At the end of the 3-month follow-up Numerical number,Potential side effects associated with each of the three treatment regimens Within 3 month after end of the intervention Patient reported outcome using a bleeding diary | — |
Countries
Thailand
Contacts
Public ContactYada Supparoekchartkul
Faculty of medicine, Siriraj hospital, Mahidol university
Outcome results
None listed