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Ectopic PregnancyPhase 4EcZOLNCT06354439

Use of Letrozole for Ectopic Pregnancy

A Phase 4 study testing Letrozole tablets and Methotrexate Sodium in people with Ectopic Pregnancy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ectopic Pregnancy
What is being tested?
Letrozole tablets and Methotrexate Sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteBrazil
Study dates
27 Mar 2024to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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)
Show all 10Show fewer
  • Hemoglobin <10 g/dl
  • Platelets <120.000/ml
  • Presence of heterotopic pregnancy
  • Do not wish to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ricardo F Savaris, MD, PhD contact

+55 51 997781966

rsavaris@hcpa.edu.br

Brazil1 site, 1 recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    RICARDO F SAVARIS, MD,PHD, 55 51 33598117, rsavaris@hcpa.edu.br

    Michele S Savaris, BBA, 555133598624, msavaris@hcpa.edu.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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

Read the 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.

Being tested
Letrozole tablets, Methotrexate Sodium
Keywords
ectopic pregnancy, letrozole, methotrexate
Medical subject headings
Pregnancy, Ectopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letrozole tabletsDrug

    Also called letrozole 2,5mg - 4 tables

    10 mg of letrozole PO for 7 days

  • Methotrexate SodiumDrug

    Also called methotrexate intramuscular (IM)

    100 mg of methotrexate IM, single dose

Study groups in NCT06354439
Study groupRoleWhat they receive
letrozoleExperimentalPatients will receive 10mg of letrozole por 7 days.
Receives: Drug: Letrozole tablets
MethotrexateActive comparatorPatients will receive a single intramuscular dose of 100 mg of methotrexate.
Receives: Drug: Methotrexate Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start27 Mar 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06354439
Sponsor's protocol ID
77015224.6.1001.5327
Acronym
EcZOL
Status last verified
Apr 2024
First submitted
1 Apr 2024
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected anonymized data will available so others may reproduce the results

Publications

  • Link CA, Maissiat J, Mol BW, Barnhart KT, Savaris RF. Diagnosing ectopic pregnancy using Bayes theorem: a retrospective cohort study. Fertil Steril. 2023 Jan;119(1):78-86. doi: 10.1016/j.fertnstert.2022.09.016. Epub 2022 Oct 26.

    PubMed 36307292

  • Farquhar CM. Ectopic pregnancy. Lancet. 2005 Aug 13-19;366(9485):583-91. doi: 10.1016/S0140-6736(05)67103-6.

    PubMed 16099295

  • Bouyer J, Coste J, Fernandez H, Pouly JL, Job-Spira N. Sites of ectopic pregnancy: a 10 year population-based study of 1800 cases. Hum Reprod. 2002 Dec;17(12):3224-30. doi: 10.1093/humrep/17.12.3224.

    PubMed 12456628

  • van Mello NM, Mol F, Ankum WM, Mol BW, van der Veen F, Hajenius PJ. Ectopic pregnancy: how the diagnostic and therapeutic management has changed. Fertil Steril. 2012 Nov;98(5):1066-73. doi: 10.1016/j.fertnstert.2012.09.040.

    PubMed 23084008

  • Diagnosis and Management of Ectopic Pregnancy: Green-top Guideline No. 21. BJOG. 2016 Dec;123(13):e15-e55. doi: 10.1111/1471-0528.14189. Epub 2016 Nov 3. No abstract available.

    PubMed 27813249

  • Qian X, Li Z, Ruan G, Tu C, Ding W. Efficacy and toxicity of extended aromatase inhibitors after adjuvant aromatase inhibitors-containing therapy for hormone-receptor-positive breast cancer: a literature-based meta-analysis of randomized trials. Breast Cancer Res Treat. 2020 Jan;179(2):275-285. doi: 10.1007/s10549-019-05464-w. Epub 2019 Oct 12.

    PubMed 31606823

  • Casper RF, Mitwally MF. Use of the aromatase inhibitor letrozole for ovulation induction in women with polycystic ovarian syndrome. Clin Obstet Gynecol. 2011 Dec;54(4):685-95. doi: 10.1097/GRF.0b013e3182353d0f.

    PubMed 22031258

  • Auger N, Ayoub A, Wei SQ. Letrozole: future alternative to methotrexate for treatment of ectopic pregnancy? Fertil Steril. 2020 Aug;114(2):273-274. doi: 10.1016/j.fertnstert.2020.04.063. Epub 2020 Jul 1. No abstract available.

    PubMed 32622661

  • Mitwally MF, Hozayen WG, Hassanin KMA, Abdalla KA, Abdalla NK. Aromatase inhibitor letrozole: a novel treatment for ectopic pregnancy. Fertil Steril. 2020 Aug;114(2):361-366. doi: 10.1016/j.fertnstert.2020.04.001. Epub 2020 Jul 1.

    PubMed 32622660

  • Rezaei Z, Ghaemi M, Feizabad E, Ghavami B, Akbari Asbagh F, Davari Tanha F, Ebrahimi M, Khalaj Sereshki Z. The Effective Role of Adding Letrozole to Methotrexate in the Management of Tubal Ectopic Pregnancies, a Randomized Clinical Trial. Iran J Pharm Res. 2021 Fall;20(4):378-384. doi: 10.22037/ijpr.2021.115659.15461.

    PubMed 35194453

  • Alabiad MA, Said WMM, Gad AH, Sharaf ElDin MTA, Khairy DA, Gobran MA, Shalaby AM, Samy W, Abdelsameea AA, Heraiz AI. Evaluation of Different Doses of the Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy and Its Effect on Villous Trophoblastic Tissue. Reprod Sci. 2022 Oct;29(10):2983-2994. doi: 10.1007/s43032-022-00993-0. Epub 2022 Jun 14.

    PubMed 35701686

  • Lipscomb GH, Gomez IG, Givens VM, Meyer NL, Bran DF. Yolk sac on transvaginal ultrasound as a prognostic indicator in the treatment of ectopic pregnancy with single-dose methotrexate. Am J Obstet Gynecol. 2009 Mar;200(3):338.e1-4. doi: 10.1016/j.ajog.2008.12.006.

    PubMed 19254596

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Letrozole tablets and Methotrexate Sodium in people with Ectopic Pregnancy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ricardo F Savaris, MD, PhD (+55 51 997781966, rsavaris@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06354439, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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