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A randomized controlled trial comparing the use of combined hormonal contraceptives for 1 month, 2 months, and a placebo in the prevention of abnormal vaginal bleeding associated with the 3-year contraceptive implant; A BLOOM trial.

A randomized controlled trial comparing the use of combined hormonal contraceptives for 1 month, 2 months, and a placebo in the prevention of abnormal vaginal bleeding associated with the 3-year contraceptive implant; A BLOOM trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250725003
Enrollment
90
Registered
2025-07-25
Start date
2025-01-16
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy female volunteers aged 18 to 45 years, using contraceptive implant. healthy women combined contraceptive contraceptive implant vaginal bleeding randomised controlled trial

Interventions

Combine contraceptive 1 month after implant,Combine contraceptive 2 month after implant,no treatment
Combine contraceptive 1 month ,Combine contraceptive 2 month ,placebo

Sponsors

Nakornping Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women of reproductive age, 18 to45 years old No underlying diseases, or any conditions contraindicating hormonal contraceptive use such as bleeding disorders (easy bruising or prolonged bleeding), abnormal liver or kidney function, or a history of breast cancer Able to understand and communicate in Thai

Exclusion criteria

Exclusion criteria: Women of reproductive age who are currently breastfeeding or are within 6 months postpartum Individuals who have previously used contraceptive implants Individuals with abnormal vaginal bleeding or spotting prior to receiving the contraceptive implant Individuals allergic to combined hormonal contraceptives

Design outcomes

Primary

MeasureTime frame
duration of vaginal bleeding 3 month metric

Secondary

MeasureTime frame
satisfaction 3 months score

Countries

Thailand

Contacts

Public ContactSuparat Kanjanavanit

Nakornping Hospital, Thailand

suparat_ka@up.ac.th053999200

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026