Evaluation of Different Doses of Letrozole in Ectopic Pregnancy (letrezole)
Primary Purpose
Ectopic Pregnancy
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole tablets
laparoscopic salpingectomy
Sponsored by
About this trial
This is an interventional treatment trial for Ectopic Pregnancy focused on measuring LETREZOLE, Ectopic pregnancy, Induced abortion
Eligibility Criteria
Inclusion Criteria:
- Diagnosed ectopic pregnancy was by
- Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
- β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Exclusion Criteria:
- Patients had contraindications for letrozole
- Patients with any systemic disease ( diabetes, hypertension, ....)
- Patients with b-hCG levels >3,000 mIU/mL
- Patients with hemoglobin level <10 g/dL,
- Patients with platelets count <150,000/mL,
- Patients with elevated liver enzymes,
- Patients with elevated blood urea, or serum creatinine
- The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
Sites / Locations
- Mohamed ALI Alabiad
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group I (GI)
low dose letrozole group II (GII)
High dose letrozole group (GIII)
Arm Description
Patients who were undergoing surgical treatment
patients who were medically treated with 5 mg of letrozole
patients who were medically treated with 10 mg of letrozole using
Outcomes
Primary Outcome Measures
β-hCG level
A quantitative human chorionic gonadotropin
β-hCG level
A quantitative human chorionic gonadotropin
Secondary Outcome Measures
Complete blood count (CBC)
Complete blood count
Alanine Amino Transferase (ALT)
Liver enzyme
Aspartate aminotransferase (AST)
Liver enzyme
Serum creatinine
Renal function test
Blood urea
Renal function test
Complete blood count (CBC)
Complete blood count
Alanine Amino Transferase (ALT)
Liver enzyme
Aspartate aminotransferase (AST)
Liver enzyme
Serum creatinine
Renal function test
Blood urea
Renal function test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05198141
Brief Title
Evaluation of Different Doses of Letrozole in Ectopic Pregnancy
Acronym
letrezole
Official Title
Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.
Detailed Description
Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: The control group that contained women who were undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1) for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d. After that, the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after 11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue. The utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
LETREZOLE, Ectopic pregnancy, Induced abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group I (GI)
Arm Type
Active Comparator
Arm Description
Patients who were undergoing surgical treatment
Arm Title
low dose letrozole group II (GII)
Arm Type
Experimental
Arm Description
patients who were medically treated with 5 mg of letrozole
Arm Title
High dose letrozole group (GIII)
Arm Type
Experimental
Arm Description
patients who were medically treated with 10 mg of letrozole using
Intervention Type
Drug
Intervention Name(s)
Letrozole tablets
Other Intervention Name(s)
Femara
Intervention Description
GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III)
Intervention Type
Procedure
Intervention Name(s)
laparoscopic salpingectomy
Intervention Description
laparoscopic salpingectomy
Primary Outcome Measure Information:
Title
β-hCG level
Description
A quantitative human chorionic gonadotropin
Time Frame
The β-hCG levels were assessed on the 1st of treatment
Title
β-hCG level
Description
A quantitative human chorionic gonadotropin
Time Frame
The β-hCG levels were assessed on the 11th day of treatment
Secondary Outcome Measure Information:
Title
Complete blood count (CBC)
Description
Complete blood count
Time Frame
Assessed on the 1st day of treatment
Title
Alanine Amino Transferase (ALT)
Description
Liver enzyme
Time Frame
Assessed on the 1st and 11th day of treatment
Title
Aspartate aminotransferase (AST)
Description
Liver enzyme
Time Frame
Assessed on the 1st and 11th day of treatment
Title
Serum creatinine
Description
Renal function test
Time Frame
Assessed on the 1st and 11th day of treatment
Title
Blood urea
Description
Renal function test
Time Frame
Assessed on the 1st and 11th day of treatment
Title
Complete blood count (CBC)
Description
Complete blood count
Time Frame
Assessed on the 11th day of treatment
Title
Alanine Amino Transferase (ALT)
Description
Liver enzyme
Time Frame
Assessed on the 11th day of treatment
Title
Aspartate aminotransferase (AST)
Description
Liver enzyme
Time Frame
Assessed on the 11th day of treatment
Title
Serum creatinine
Description
Renal function test
Time Frame
Assessed on the 11th day of treatment
Title
Blood urea
Description
Renal function test
Time Frame
Assessed on the 11th day of treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed ectopic pregnancy was by
Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Exclusion Criteria:
Patients had contraindications for letrozole
Patients with any systemic disease ( diabetes, hypertension, ....)
Patients with b-hCG levels >3,000 mIU/mL
Patients with hemoglobin level <10 g/dL,
Patients with platelets count <150,000/mL,
Patients with elevated liver enzymes,
Patients with elevated blood urea, or serum creatinine
The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed I Heraiz, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed ALI Alabiad
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
14150
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Table Statistical analysis Master sheet raw data (excel sheet)
IPD Sharing Time Frame
the data will become available after one month from the approval and will be available for three months
IPD Sharing Access Criteria
you can send a Data request email to Dr: Mohamed at drno99@yahoo.com
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.staffdata.zu.edu.eg/ar/ShowData/23528
Available IPD/Information Comments
you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
http://www.staffdata.zu.edu.eg/ar/ShowData/23528
Available IPD/Information Identifier
drno99@yahoo.com
Available IPD/Information Comments
you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://www.staffdata.zu.edu.eg/ar/ShowData/23528
Available IPD/Information Comments
you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.staffdata.zu.edu.eg/ar/ShowData/23528
Available IPD/Information Comments
you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
Learn more about this trial
Evaluation of Different Doses of Letrozole in Ectopic Pregnancy
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