Status:
COMPLETED
Treatment of Prolonged Uterine Bleeding of Etonogestrel (ENG)-Releasing Implant
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Organon
Conditions:
Breakthrough Bleeding
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Long-acting reversible contraceptives \[LARC; copper-intrauterine devices (IUDs), the levonorgestrel-releasing intrauterine system (LNG-IUS) and subdermal implants\] are the most effective reversible ...
Eligibility Criteria
Inclusion
- To be an etonogestrel-releasing implant user for at least 40 days with a current bleeding/spotting episode of at least 7 consecutive days;
- Age between 18-40 years old;
- To have a mobile phone.
Exclusion
- Body mass index (BMI; kg/m2) ≥ 35;
- Pregnancy;
- To have a positive chlamydia test;
- To be unable or unwilling to swallow pills;
- To have a medical condition deemed severe by a physician investigator;
- To be in use of a hepatic enzyme inducing medication;
- To be in use of anticoagulant drug;
- To have findings on speculum examination indicating an anatomic source of bleeding (e.g., polyp, cervicitis);
- To be in the first 6 months of delivery;
- To be on a concurrent hormonal contraceptive, depot medroxyprogesterone acetate (DMPA) interruption ≤ 6 months;
- To be illiterate;
- To be in use of any drug to stop the bleeding associated with etonogestrel implant ≤ 15 days.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04047875
Start Date
September 15 2020
End Date
May 5 2023
Last Update
September 23 2024
Active Locations (2)
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1
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14015-010
2
UNIFESP
São Paulo, São Paulo, Brazil, 04023-061