Unscheduled bleeding in levonorgestrel-releasing contraceptive implant (Jadelle) users Levonorgestrel Combined Oral Contraceptive Pills Contraceptive implant Abnormal uterine bleeding Tamoxifen Breakthrough Bleeding Randomized Controlled Trial
Conditions
Interventions
Participants will receive Tamoxifen 10 mg (tablet form) to be taken orally twice daily (every 12 hours) for a duration of 10 consecutive days.,Participants will receive a Combined Oral Contraceptive P
Experimental Drug,Active Comparator Drug
Tamoxifen (10 mg twice daily for 10 days),Combined Oral Contraceptive Pills (COCs)
Sponsors
Lampang Hospital, Thailand
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 18-45 years 2. Current use of the Levonorgestrel contraceptive implant (Jadelle) for more than 3 months 3. Patients experiencing abnormal uterine bleeding having abnormal bleeding lasting for more than 7 days
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal uterine bleeding caused by other conditions, such as uterine tumors, endometritis, or cervicitis. 2. Patients who have received any type of medical treatment for abnormal uterine bleeding within the 90 days prior to participating in the study. 3. Patients who are currently taking anticoagulant medications or those who have a blood coagulation disorder. 4. Patients who are 6 months or less postpartum. 5. Patients who are currently breastfeeding. 6. Patients using medications that may affect the efficacy of Tamoxifen, such as Letrozole, Rifampin, Bromocriptine, or Phenobarbital. 7. Patients with contraindications to Tamoxifen, including: A history of allergy to Tamoxifen, history or current presence of thromboembolism, such as a history or current occurrence of ischemic stroke, coronary artery disease, or myocardial infarction, history of endometrial cancer. 8. Patients with contraindications to combined oral contraceptive pills according to the WHO Medical Eligibility Criteria for Contraceptive Use 2025, or a history of allergy to combined oral contraceptives. 9. Patients who are unable to use or cannot record their abnormal uterine bleeding data via the application designated by the research project. 10. Patients who receive other medications or alternative treatments for abnormal bleeding caused by the contraceptive implant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration from completion of treatment to cessation of bleeding at 30 days after end of the intervention A digital daily bleeding diary recorded | — |
Secondary
| Measure | Time frame |
|---|---|
| the total number of bleeding days after end of the intervention at 30 days after end of the intervention A digital daily bleeding diary recorded,time to recurrence of unscheduled bleeding at 30 days after end of the intervention A digital daily bleeding diary recorded,incidence of treatment-related side effects, including hot flashes, mood swings, headache, nausea, breast tenderness, and fatigue within 30 days after end of the intervention A digital daily diary recorded | — |
Countries
Thailand
Contacts
Public ContactPhattharat Phunpae
Lampang Hospital
Outcome results
None listed