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Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05198141
Acronym
letrezole
Enrollment
60
Registered
2022-01-20
Start date
2020-12-15
Completion date
2022-01-01
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopic Pregnancy

Keywords

LETREZOLE, Ectopic pregnancy, Induced abortion

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.

Interventions

laparoscopic salpingectomy

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)

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
β-hCG levelThe β-hCG levels were assessed on the 1st of treatmentA quantitative human chorionic gonadotropin

Secondary

MeasureTime frameDescription
Complete blood count (CBC)Assessed on the 1st day of treatmentComplete blood count
Alanine Amino Transferase (ALT)Assessed on the 1st and 11th day of treatmentLiver enzyme
Aspartate aminotransferase (AST)Assessed on the 1st and 11th day of treatmentLiver enzyme
Serum creatinineAssessed on the 1st and 11th day of treatmentRenal function test
Blood ureaAssessed on the 1st and 11th day of treatmentRenal function test

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026