Study Results
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Basic Information
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RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2024-03-27
2026-12-31
Brief Summary
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Letrozole in Tubal Ectopic Pregnancy
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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letrozole
Patients will receive 10mg of letrozole por 7 days.
Letrozole tablets
10 mg of letrozole PO for 7 days
Methotrexate
Patients will receive a single intramuscular dose of 100 mg of methotrexate.
Methotrexate Sodium
100 mg of methotrexate IM, single dose
Interventions
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Letrozole tablets
10 mg of letrozole PO for 7 days
Methotrexate Sodium
100 mg of methotrexate IM, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Ricardo F Savaris, MD, PhD
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Farquhar CM. Ectopic pregnancy. Lancet. 2005 Aug 13-19;366(9485):583-91. doi: 10.1016/S0140-6736(05)67103-6.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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77015224.6.1001.5327
Identifier Type: -
Identifier Source: org_study_id
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