NCT06354439 Use of Letrozole for Ectopic Pregnancy
| NCT ID | NCT06354439 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Ectopic Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2024-03-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate
Eligibility Criteria
Inclusion Criteria: * 18 years or older * Diagnosis of ectopic pregnancy * Desire for reproduction * Ease of return * Undetermined pregnancy location with abnormal hCG growth * Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml * Absence of fetal cardiac activity * Average diameter of the adnexal mass ≤ 3.5 cm * Hemodynamically stable * No significant abdominal pain (i.e, \< 6 on a visual analog scale) Exclusion Criteria: * Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician) * Allergy to methotrexate or letrozole * A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization * Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal) * Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min) * Hemoglobin \<10 g/dl * Platelets \<120.000/ml * Presence of heterotopic pregnancy * Do not wish to participate in the study.
Contact & Investigator
Ricardo F Savaris, MD, PhD
STUDY CHAIR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT06354439 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ectopic Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06354439 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06354439 currently recruiting?
Yes, NCT06354439 is actively recruiting participants. Contact the research team at rsavaris@hcpa.edu.br for enrollment information.
Where is the NCT06354439 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06354439 clinical trial?
NCT06354439 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Ricardo F Savaris, MD, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 130 participants.