Evaluation of Different Doses of Letrozole in Ectopic Pregnancy (letrezole)

Zagazig University

Status and phase: Completed; Phase 4

Conditions: Ectopic Pregnancy

Treatments: Procedure: laparoscopic salpingectomy; Drug: Letrozole tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05198141

LETROZOLE ON ECTOPIC PREGNANCY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control group I (GI)

Active Comparator group

Description:

Patients who were undergoing surgical treatment

Treatment:

Procedure: laparoscopic salpingectomy

low dose letrozole group II (GII)

Experimental group

Description:

patients who were medically treated with 5 mg of letrozole

Treatment:

Drug: Letrozole tablets

High dose letrozole group (GIII)

Experimental group

Description:

patients who were medically treated with 10 mg of letrozole using

Treatment:

Drug: Letrozole tablets