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letrezole: Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05198141
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
12.6
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Letrozole tablets
  • Procedure: laparoscopic salpingectomy
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
Actual Study Start Date :
Dec 15, 2020
Actual Primary Completion Date :
Nov 20, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group I (GI)

Patients who were undergoing surgical treatment

Procedure: laparoscopic salpingectomy
laparoscopic salpingectomy
Experimental: low dose letrozole group II (GII)

patients who were medically treated with 5 mg of letrozole

Drug: Letrozole tablets
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)
Other Names:
  • Femara

    		•
    Experimental: High dose letrozole group (GIII)

    patients who were medically treated with 10 mg of letrozole using

    Drug: Letrozole tablets
    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)
    Other Names:
  • Femara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. β-hCG level [The β-hCG levels were assessed on the 1st of treatment]

      A quantitative human chorionic gonadotropin

    2. β-hCG level [The β-hCG levels were assessed on the 11th day of treatment]

      A quantitative human chorionic gonadotropin

    Secondary Outcome Measures

    1. Complete blood count (CBC) [Assessed on the 1st day of treatment]

      Complete blood count

    2. Alanine Amino Transferase (ALT) [Assessed on the 1st and 11th day of treatment]

      Liver enzyme

    3. Aspartate aminotransferase (AST) [Assessed on the 1st and 11th day of treatment]

      Liver enzyme

    4. Serum creatinine [Assessed on the 1st and 11th day of treatment]

      Renal function test

    5. Blood urea [Assessed on the 1st and 11th day of treatment]

      Renal function test

    6. Complete blood count (CBC) [Assessed on the 11th day of treatment]

      Complete blood count

    7. Alanine Amino Transferase (ALT) [Assessed on the 11th day of treatment]

      Liver enzyme

    8. Aspartate aminotransferase (AST) [Assessed on the 11th day of treatment]

      Liver enzyme

    9. Serum creatinine [Assessed on the 11th day of treatment]

      Renal function test

    10. Blood urea [Assessed on the 11th day of treatment]

      Renal function test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohamed ALI Alabiad Zagazig Sharkia Egypt 14150

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Ahmed I Heraiz, MD, Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Ali Alabiad, MD, Principal Investigator, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05198141
    Other Study ID Numbers:
    • LETROZOLE ON ECTOPIC PREGNANCY
    First Posted:
    Jan 20, 2022
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Mohamed Ali Alabiad, MD, Principal Investigator, Zagazig University
    LETREZOLE
    Ectopic pregnancy
    Induced abortion
    Additional relevant MeSH terms:
    Pregnancy, Ectopic
    Cardiac Complexes, Premature
    Letrozole

    Study Results

    No Results Posted as of Jan 20, 2022