Use of Letrozole for Ectopic Pregnancy

NCT06354439 | Recruiting Phase 4

• 1 other identifier: 77015224.6.1001.5327
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ectopic Pregnancy

Keywords

ectopic pregnancy; letrozole; methotrexate

Outcome Measures

Primary Outcomes (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).

  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)"

Study Arms (2)

letrozole

EXPERIMENTAL

Patients will receive 10mg of letrozole por 7 days.

Drug: Letrozole tablets

Methotrexate

ACTIVE COMPARATOR

Patients will receive a single intramuscular dose of 100 mg of methotrexate.

Drug: Methotrexate Sodium

Interventions

Letrozole tablets DRUG

10 mg of letrozole PO for 7 days

Also known as: letrozole 2,5mg - 4 tables

letrozole

Methotrexate Sodium DRUG

100 mg of methotrexate IM, single dose

Also known as: methotrexate intramuscular (IM)

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: ciswomen with ectopic pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (12)

• 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.

  PMID: 36307292 BACKGROUND

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

  PMID: 16099295 BACKGROUND

• 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.

  PMID: 12456628 BACKGROUND

• 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.

  PMID: 23084008 BACKGROUND

• 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.

  PMID: 27813249 BACKGROUND

• 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.

  PMID: 31606823 BACKGROUND

• 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.

  PMID: 22031258 BACKGROUND

• 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.

  PMID: 32622661 BACKGROUND

• 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.

  PMID: 32622660 BACKGROUND

• 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.

  PMID: 35194453 BACKGROUND

• 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.

  PMID: 35701686 BACKGROUND

• 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.

  PMID: 19254596 BACKGROUND

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Letrozole; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ricardo F Savaris, MD, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Central Study Contacts

Ricardo F Savaris, MD, PhD

CONTACT

+55 51 997781966; rsavaris@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the outcome and the interventions, blinding was not considered an issue.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 9, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: march 28, 2024 until march 28 2044
• Access Criteria: open access

Locations

BR (1)