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ACTIVE NOT RECRUITING
NCT07842796
PHASE2/PHASE3

Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.

Sponsor: Benha University

View on ClinicalTrials.gov

Summary

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.

Official title: Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.

Key Details

Gender

FEMALE

Age Range

24 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-12-15

Completion Date

2026-12-12

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

Letrozole

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.

DRUG

Methotrexate

A single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is \<10 on Day 4,

Locations (1)

Benha university

Banhā, El Qalyoubia, Egypt