Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

NCT07624903 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Ectopic Pregnancy Manegement
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of work is to study the effectiveness of letrozole in treatment of early undisturbed ectopic pregnancy in comparison with Methotrexate.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• Resolution of complain

  follow up by β-hCG on day 4 and day 7 of first dose

  β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).

Study Arms (2)

Methotrexate

ACTIVE COMPARATOR

Group 1 : 35 of patients with early undisturbed ectopic pregnancy will receive methotrexate (1mg\\kg IM) and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department ., Faculty of Medicine, Kafrelsheikh University Hospitals. At day 7 If β-hCG decrease \>15% than day 4 , β-hCG will be repeated weekly till negative but If β-hCG decrease \< 15% than day 4 second dose of methotrexate will be given 50mg/m2 IM and follow up weekly (maximum dose is 4 doses) .

Drug: Methotrexate (drug)

Letrozole

ACTIVE COMPARATOR

Groub 2 : 35 of patients with early undisturbed ectopic pregnancy will receive letrozole (2.5 mg three times daily) for 10 days and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department, Faculty of Medicine, Kafrelsheikh University Hospitals . Patients who had no success response to letrozole (β-hCG not decreased by 30% after 10 days ) , laparoscopy will be done .

Drug: Letrozole 2.5Mg Tab

Interventions

Methotrexate (drug) DRUG

Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis

Methotrexate

Letrozole 2.5Mg Tab DRUG

Aromatase inhibitors has been shown toSuccessfully block estrogen production In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors. It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancy

Letrozole

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed ectopic pregnancy on trans vaginal ultrasound
• Age between 20 and 35 years
• A β-hCG levels \< 3000 Iu/ L
• The average diameter of the adnexal mass ≤3.5 cm
• Stable hemodynamic condition

You may not qualify if:

• Presence of fetal heart pulsation
• Heterotopic pregnancy
• Presence of significant abdominal pain
• history of allergic reactions to MTX or letrozole
• Any known liver disorder or abnormal liver enzyme levels (AST or ALT )
• Any known renal disorder or impaired renal function tests (abnormal creatinine)

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate; Pharmaceutical Preparations; Letrozole

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Walid Mamdouh Atallah, OBGYN Professor

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

Aya Fekry Saad Bahnasy, Obstetrics&Gynecology resident

CONTACT

+201092178164; ayafekry772@gmail.com

Mostafa Farag Ellakany, Obstetrics&Gynecology Lecturer

CONTACT

+2010116083210; mfe_2014@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)