Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

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Brief Title

Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Official Title

Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

β-hCG level

Secondary Outcome

 Complete blood count (CBC)

Condition

Ectopic Pregnancy

Intervention

Letrozole tablets

Study Arms / Comparison Groups

 Control group I (GI)
Description:  Patients who were undergoing surgical treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

December 15, 2020

Completion Date

January 1, 2022

Primary Completion Date

November 20, 2021

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
      

Gender

Female

Ages

19 Years - 35 Years

Accepts Healthy Volunteers

No

Contacts

Ahmed I Heraiz, MD, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05198141

Organization ID

LETROZOLE ON ECTOPIC PREGNANCY


Responsible Party

Principal Investigator

Study Sponsor

Zagazig University


Study Sponsor

Ahmed I Heraiz, MD, Principal Investigator, Zagazig University


Verification Date

January 2022