Monotherapy With Letrozole in Tubal Pregnancy

November 16, 2023 updated by: Iwona Magdalena Gawron, Jagiellonian University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Poland
      • Krakow, Poland, 31-501
        • Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • tubal pregnancy confirmed on pelvic ultrasound
  • increasing serum B-hCG concentrations in at least two subsequent measures
  • serum B-hCG concentration ≤ 3000 mIU/ml

Exclusion Criteria:

  • free fluid in lesser pelvis on pelvic ultrasound
  • positive fetal heartbeat on pelvic ultrasound
  • abdominal pain
  • heterotopic pregnancy
  • contraindications to MTX

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tubal pregnancy treated with MTX
MTX in a single dose of 100 mg intravenously on day 0
Drug: MTX as monotherapy
MTX in a single dose of 100 mg intravenously on day 0
Active Comparator: Tubal pregnancy treated with letrozole
Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0
Drug: Letrozole as monotherapy
Letrozole 5 mg daily orally for 10 days from day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of the treatment
Time Frame: up to 6 months
Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of treatment on bone marrow function (hemoglobin)
Time Frame: up to 6 months
Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on bone marrow function (red blood cells)
Time Frame: up to 6 months
Changes in red blood cell count (T/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on bone marrow function (white blood cells)
Time Frame: up to 6 months
Changes in white blood count (G/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on bone marrow function (platelets)
Time Frame: up to 6 months
Changes in platelet count (G/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on liver function (total bilirubin)
Time Frame: up to 6 months
Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on liver function (alanine transaminase)
Time Frame: up to 6 months
Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on liver function (aspartate transaminase)
Time Frame: up to 6 months
Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on liver function (gamma-glutamyltransferase)
Time Frame: up to 6 months
Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on kidney function (urea)
Time Frame: up to 6 months
Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)
up to 6 months
The effect of treatment on kidney function (creatinine)
Time Frame: up to 6 months
Changes in the concentrations of serum creatinine (mg/dl) in the course of treatment (day 0,4,7)
up to 6 months

Collaborators and Investigators

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

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Robert Jach, Prof., Ph.D., Jagiellonian University

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)

December 1, 2020

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.321.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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