A Phase 2/3 interventional study of Letrozole and Methotrexate in Ectopic Pregnancy, sponsored by Benha University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 24 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Benha University · Phase 2/3, Interventional, and Treatment
This study evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Participants with undisturbed TEP and pre-treatment serum $\beta$-hCG levels $\<3500\text{ IU/L}$ are randomized to receive either a sequential regimen (initial letrozole monotherapy, reserving MTX only for treatment non-responders) or a combined regimen (simultaneous letrozole and single-dose MTX from day one). The study aims to compare the overall success rate of resolving TEP without emergency surgery, as well as the ability of the sequential approach to avoid MTX administration altogether.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 144 is above the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Participants in this arm initially receive oral Letrozole at a dose of 5 mg daily (administered as two 2.5 mg film-coated tablets once daily) for 4 consecutive days. On Day 4, serum beta-hCG levels are evaluated to specify if rescue needed we will give a single intramuscular rescue injection of Methotrexate (50mg/m) while continuing Letrozole for an additional 7 days.
Drug: Letrozole · Drug: Methotrexate
Participants in this arm receive simultaneous dual drug therapy starting on Day 1
Drug: Letrozole · Drug: Methotrexate
Oral Letrozole 5 mg/day (2 times 2.5{ mg} tablets daily) for 4 days. If serum beta-hCG drops by \>10% on Day 4, Letrozole is continued.
A single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is \<10 on Day 4,
Letrozole Standalone Success Rate
Resolution of tubal ectopic pregnancy (confirmed by TVU and beta-hCG \< 15 IU/L) achieved via Letrozole monotherapy without requiring Methotrexate or surgical intervention
Time frame: 19 days post-initiation oftreatment treatment.
Avoidance of Surgery
: Resolution of ectopic pregnancy (beta-hCG \< 15 IU/L) using medical management alone, avoiding conversion to emergency surgery (salpingectomy/salpingotomy).
Time frame: 19 days post-initiation oftreatment treatment.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Letrozole · Methotrexate