Using Letrozole to Treat Ectopic Pregnancy
Use of Letrozole in the Treatment of Early Ectopic Pregnancy
This study is testing if a daily pill called letrozole can effectively treat early ectopic pregnancies just as well as the usual shot of methotrexate.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT06354439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of oral letrozole, administered at a dose of 10mg per day for 7 days, in treating early cases of ectopic pregnancy. It is a multicenter, randomized trial comparing letrozole to the standard treatment of intramuscular methotrexate. The study aims to determine if letrozole is non-inferior to methotrexate in managing hemodynamically stable women diagnosed with tubal ectopic pregnancy. Participants will be monitored for their response to treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of early ectopic pregnancy who are hemodynamically stable and desire to preserve their reproductive options.
Not a fit: Patients with significant abdominal pain, abnormal liver or renal function, or those who have shown a significant decrease in hCG levels prior to randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more convenient option for women with ectopic pregnancies.
How similar studies have performed: While methotrexate is a well-established treatment for ectopic pregnancy, the use of letrozole is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Ricardo F Savaris, MD, PhD
- Email: rsavaris@hcpa.edu.br
- Phone: +55 51 997781966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.