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Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Primary Purpose

Ectopic Pregnancy

Status
Active
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Letrozole
methotrexate
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed. Exclusion Criteria: B-HCG levels more or equal to 5000 Hemoglobin level less than 10 g/dl Platelet level less than 100,000 Increasing the level of liver function tests and the level of urea and creatinine The presence of fetal heart activity in the gestational sac

Sites / Locations

  • Imam Khomeini Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

methotrexate

Letrozole BD

Letroozole TDS

Arm Description

The first group will receive a single dose (50 mg/m2) of methotrexate The beta-hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

The first group will receive letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Outcomes

Primary Outcome Measures

βhCG
Anti mulerian hormone

Secondary Outcome Measures

Full Information

First Posted
April 8, 2023
Last Updated
June 23, 2023
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05918718
Brief Title
Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy
Official Title
Assessment of the Efficacy of Letrozole in Comparison to Methotrexate in the Treatment of Ectopic Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
In this study, about 75 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day. In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured. In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14. Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment. The level of antimullerin hormone is measured on the first day and 3 months after the treatment.
Detailed Description
In this study, about 75 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day. In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured. In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14. Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment. The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methotrexate
Arm Type
Experimental
Arm Description
The first group will receive a single dose (50 mg/m2) of methotrexate The beta-hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.
Arm Title
Letrozole BD
Arm Type
Experimental
Arm Description
The first group will receive letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.
Arm Title
Letroozole TDS
Arm Type
Experimental
Arm Description
letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
assessment of the efficacy of Letrozole in treatment of ectopic pregnancy
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
methotrexate
Primary Outcome Measure Information:
Title
βhCG
Time Frame
on day 14
Title
Anti mulerian hormone
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed. Exclusion Criteria: B-HCG levels more or equal to 5000 Hemoglobin level less than 10 g/dl Platelet level less than 100,000 Increasing the level of liver function tests and the level of urea and creatinine The presence of fetal heart activity in the gestational sac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
azadeh tarafdari
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Imam Khomeini Hospital Complex
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

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