letrezole: Evaluation of Different Doses of Letrozole in Ectopic Pregnancy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Control group I (GI) Patients who were undergoing surgical treatment |
Procedure: laparoscopic salpingectomy
laparoscopic salpingectomy
|
Experimental: low dose letrozole group II (GII) patients who were medically treated with 5 mg of letrozole |
Drug: Letrozole tablets
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:
|
Experimental: High dose letrozole group (GIII) patients who were medically treated with 10 mg of letrozole using |
Drug: Letrozole tablets
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:
|
Outcome Measures
Primary Outcome Measures
- β-hCG level [The β-hCG levels were assessed on the 1st of treatment]
A quantitative human chorionic gonadotropin
- β-hCG level [The β-hCG levels were assessed on the 11th day of treatment]
A quantitative human chorionic gonadotropin
Secondary Outcome Measures
- Complete blood count (CBC) [Assessed on the 1st day of treatment]
Complete blood count
- Alanine Amino Transferase (ALT) [Assessed on the 1st and 11th day of treatment]
Liver enzyme
- Aspartate aminotransferase (AST) [Assessed on the 1st and 11th day of treatment]
Liver enzyme
- Serum creatinine [Assessed on the 1st and 11th day of treatment]
Renal function test
- Blood urea [Assessed on the 1st and 11th day of treatment]
Renal function test
- Complete blood count (CBC) [Assessed on the 11th day of treatment]
Complete blood count
- Alanine Amino Transferase (ALT) [Assessed on the 11th day of treatment]
Liver enzyme
- Aspartate aminotransferase (AST) [Assessed on the 11th day of treatment]
Liver enzyme
- Serum creatinine [Assessed on the 11th day of treatment]
Renal function test
- Blood urea [Assessed on the 11th day of treatment]
Renal function test
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed ectopic pregnancy was by
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Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
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β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Exclusion Criteria:
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Patients had contraindications for letrozole
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Patients with any systemic disease ( diabetes, hypertension, ....)
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Patients with b-hCG levels >3,000 mIU/mL
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Patients with hemoglobin level <10 g/dL,
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Patients with platelets count <150,000/mL,
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Patients with elevated liver enzymes,
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Patients with elevated blood urea, or serum creatinine
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The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mohamed ALI Alabiad | Zagazig | Sharkia | Egypt | 14150 |
Sponsors and Collaborators
- Zagazig University
Investigators
- Principal Investigator: Ahmed I Heraiz, MD, Zagazig University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LETROZOLE ON ECTOPIC PREGNANCY