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