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Completed

NCT Number: NCT05198141

Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

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.

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Key information

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mohamed ALI Alabiad

Zagazig, Sharqia Province, 14150, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letrozole tablets

Drug

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

Laparoscopic salpingectomy

Procedure

laparoscopic salpingectomy

Primary outcomes

  1. β-hCG level

    Time frame: The β-hCG levels were assessed on the 1st of treatment

    A quantitative human chorionic gonadotropin

  2. β-hCG level

    Time frame: The β-hCG levels were assessed on the 11th day of treatment

    A quantitative human chorionic gonadotropin

Secondary outcomes

  1. Complete blood count (CBC)

    Time frame: Assessed on the 1st day of treatment

    Complete blood count

  2. Alanine Amino Transferase (ALT)

    Time frame: Assessed on the 1st and 11th day of treatment

    Liver enzyme

  3. Aspartate aminotransferase (AST)

    Time frame: Assessed on the 1st and 11th day of treatment

    Liver enzyme

  4. Serum creatinine

    Time frame: Assessed on the 1st and 11th day of treatment

    Renal function test

  5. Blood urea

    Time frame: Assessed on the 1st and 11th day of treatment

    Renal function test

  6. Complete blood count (CBC)

    Time frame: Assessed on the 11th day of treatment

    Complete blood count

  7. Alanine Amino Transferase (ALT)

    Time frame: Assessed on the 11th day of treatment

    Liver enzyme

  8. Aspartate aminotransferase (AST)

    Time frame: Assessed on the 11th day of treatment

    Liver enzyme

  9. Serum creatinine

    Time frame: Assessed on the 11th day of treatment

    Renal function test

  10. Blood urea

    Time frame: Assessed on the 11th day of treatment

    Renal function test

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Acronym: letrezole

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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