Use of Letrozole for Ectopic Pregnancy (EcZOL)

April 5, 2024 updated by: Hospital de Clinicas de Porto Alegre

Use of Letrozole in the Treatment of Early Ectopic Pregnancy

A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. Tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. They occurred in about 8% of all pregnancies presenting to the emergency department. Methotrexate (MTX), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy.

Letrozole is an aromatase inhibitor and can suppress estradiol levels. Some recent studies have shown that its use can be applied in cases of ectopic pregnancy.

The aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 ≤ 3000 mIU/ml
  • Absence of fetal cardiac activity
  • Average diameter of the adnexal mass ≤ 3.5 cm
  • Hemodynamically stable
  • No significant abdominal pain (i.e, < 6 on a visual analog scale)

Exclusion Criteria:

  • 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

    ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization

  • Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
  • Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)
  • Hemoglobin <10 g/dl
  • Platelets <120.000/ml
  • Presence of heterotopic pregnancy
  • Do not wish to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: letrozole
Patients will receive 10mg of letrozole por 7 days.
Drug: Letrozole tablets
10 mg of letrozole PO for 7 days
Other Names:
  • letrozole 2,5mg - 4 tables
Active Comparator: Methotrexate
Patients will receive a single intramuscular dose of 100 mg of methotrexate.
Drug: Methotrexate Sodium
100 mg of methotrexate IM, single dose
Other Names:
  • methotrexate intramuscular (IM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of beta fraction of human chorionic gonadotropin (beta-hCG)
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)"
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).
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)"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Chair: Ricardo F Savaris, MD, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77015224.6.1001.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected anonymized data will available so others may reproduce the results

IPD Sharing Time Frame

march 28, 2024 until march 28 2044

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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