NCT05839561

Monotherapy With Letrozole in Tubal Pregnancy

Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.

Detailed description

A prospective cohort study is conducted among women with tubal pregnancy. Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included. Two study arms were planned: i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0. The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration. The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.

Conditions

• Tubal Pregnancy Unruptured

Interventions

Type	Name	Description
DRUG	Letrozole as monotherapy	Letrozole 5 mg daily orally for 10 days from day 0
DRUG	MTX as monotherapy	MTX in a single dose of 100 mg intravenously on day 0

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2023-05-03
• Last updated: 2023-11-18

Locations

1 site across 1 country: Poland