Use of Letrozole for Ectopic Pregnancy
ConditionEctopic Pregnancy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital de Clinicas de Porto Alegre
About this trial
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
This trial does not accept healthy volunteersQualifiers
18 years or older
Diagnosis of ectopic pregnancy
Desire for reproduction
Ease of return
Disqualifiers
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
Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
Trial design
Design model
Parallel
Treatments tested in this trial
Letrozole tablets
Drug10 mg of letrozole PO for 7 days
Methotrexate Sodium
Drug100 mg of methotrexate IM, single dose
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: letrozoleExperimental treatment 1 intervention
Group B: MethotrexateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
levels of beta fraction of human chorionic gonadotropin (beta-hCG)
On day 4 (D4) and 7(D7), beta-hCG levels will be measured. If a reduction equal or above 15% between D4 and D7 were observed, serum beta-hCG will be measured until reach levels \< 5 milli-International unit per milliliter (mIU/ml).
Time frame
weekly after the first day of intervention until reaching levels of beta-hCG below 5 milli-International unit per milliliter (assessed up to 5 months)"Sponsors and contacts
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Source ClinicalTrials.gov