Actively Recruiting
Use of Letrozole for Ectopic Pregnancy
Led by Hospital de Clinicas de Porto Alegre · Updated on 2024-04-09
130
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate
CONDITIONS
Official Title
Use of Letrozole for Ectopic Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 3000 mIU/ml
- Absence of fetal cardiac activity
- Average diameter of the adnexal mass 64 3.5 cm
- Hemodynamically stable
- No significant abdominal pain (i.e, < 6 on a visual analog scale)
You will not qualify if you...
- 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 b2-hCG 65 50% in 2 measurements with 48 hours between them or
65 85% in 4 days, or 65 95% in 7 days before randomization
- Abnormal liver function test (Alanine transaminase (ALT) 65 2 times the upper limit of normal)
- Abnormal renal function test (glomerular filtration rate 64 45 ml/min)
- Hemoglobin <10 g/dl
- Platelets <120.000/ml
- Presence of heterotopic pregnancy
- Do not wish to participate in the study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
Research Team
R
Ricardo F Savaris, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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