Monotherapy With Letrozole in Tubal Pregnancy
Primary Purpose
Tubal Pregnancy Unruptured
Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Letrozole as monotherapy
MTX as monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Tubal Pregnancy Unruptured focused on measuring Tubal pregnancy, Methotrexate, Letrozole
Eligibility Criteria
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
Sites / Locations
- Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tubal pregnancy treated with MTX
Tubal pregnancy treated with letrozole
Arm Description
MTX in a single dose of 100 mg intravenously on day 0
Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0
Outcomes
Primary Outcome Measures
The effectiveness of the treatment
Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment
Secondary Outcome Measures
The effect of treatment on bone marrow function (hemoglobin)
Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7)
The effect of treatment on bone marrow function (red blood cells)
Changes in red blood cell count (T/l) in the course of treatment (day 0,4,7)
The effect of treatment on bone marrow function (white blood cells)
Changes in white blood count (G/l) in the course of treatment (day 0,4,7)
The effect of treatment on bone marrow function (platelets)
Changes in platelet count (G/l) in the course of treatment (day 0,4,7)
The effect of treatment on liver function (total bilirubin)
Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)
The effect of treatment on liver function (alanine transaminase)
Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)
The effect of treatment on liver function (aspartate transaminase)
Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)
The effect of treatment on liver function (gamma-glutamyltransferase)
Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)
The effect of treatment on kidney function (urea)
Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)
The effect of treatment on kidney function (creatinine)
Changes in the concentrations of serum creatinine (mg/dl) in the course of treatment (day 0,4,7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05839561
Brief Title
Monotherapy With Letrozole in Tubal Pregnancy
Official Title
Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubal Pregnancy Unruptured
Keywords
Tubal pregnancy, Methotrexate, Letrozole
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tubal pregnancy treated with MTX
Arm Type
Active Comparator
Arm Description
MTX in a single dose of 100 mg intravenously on day 0
Arm Title
Tubal pregnancy treated with letrozole
Arm Type
Active Comparator
Arm Description
Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0
Intervention Type
Drug
Intervention Name(s)
Letrozole as monotherapy
Intervention Description
Letrozole 5 mg daily orally for 10 days from day 0
Intervention Type
Drug
Intervention Name(s)
MTX as monotherapy
Intervention Description
MTX in a single dose of 100 mg intravenously on day 0
Primary Outcome Measure Information:
Title
The effectiveness of the treatment
Description
Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
The effect of treatment on bone marrow function (hemoglobin)
Description
Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on bone marrow function (red blood cells)
Description
Changes in red blood cell count (T/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on bone marrow function (white blood cells)
Description
Changes in white blood count (G/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on bone marrow function (platelets)
Description
Changes in platelet count (G/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on liver function (total bilirubin)
Description
Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on liver function (alanine transaminase)
Description
Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on liver function (aspartate transaminase)
Description
Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on liver function (gamma-glutamyltransferase)
Description
Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on kidney function (urea)
Description
Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
Title
The effect of treatment on kidney function (creatinine)
Description
Changes in the concentrations of serum creatinine (mg/dl) in the course of treatment (day 0,4,7)
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jach, Prof., Ph.D.
Organizational Affiliation
Jagiellonian University
Official's Role
Study Chair
Facility Information:
Facility Name
Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Monotherapy With Letrozole in Tubal Pregnancy
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