Clinical trial NCT05198141: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ectopic Pregnancy
Keywords: LETREZOLE
Ectopic pregnancy
Induced abortion
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-01-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: β-hCG level
timeFrame: The β-hCG levels were assessed on the 1st of treatment
measure: β-hCG level
timeFrame: The β-hCG levels were assessed on the 11th day of treatment
Secondary outcomes:
measure: Complete blood count (CBC)
timeFrame: Assessed on the 1st day of treatment
measure: Alanine Amino Transferase (ALT)
timeFrame: Assessed on the 1st and 11th day of treatment
measure: Aspartate aminotransferase (AST)
timeFrame: Assessed on the 1st and 11th day of treatment
measure: Serum creatinine
timeFrame: Assessed on the 1st and 11th day of treatment
measure: Blood urea
timeFrame: Assessed on the 1st and 11th day of treatment
measure: Complete blood count (CBC)
timeFrame: Assessed on the 11th day of treatment
measure: Alanine Amino Transferase (ALT)
timeFrame: Assessed on the 11th day of treatment
measure: Aspartate aminotransferase (AST)
timeFrame: Assessed on the 11th day of treatment
measure: Serum creatinine
timeFrame: Assessed on the 11th day of treatment
measure: Blood urea
timeFrame: Assessed on the 11th day of treatment
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Mohamed ALI Alabiad
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Ahmed I Heraiz, MD
role: PRINCIPAL_INVESTIGATOR
References: