A Phase 4 interventional study of Letrozole tablets and laparoscopic salpingectomy in Ectopic Pregnancy, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by Zagazig University · Phase 4, Interventional, and Treatment
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.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who were undergoing surgical treatment
Procedure: laparoscopic salpingectomy
patients who were medically treated with 5 mg of letrozole
Drug: Letrozole tablets
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)
Also known as: Femara
laparoscopic salpingectomy
β-hCG level
A quantitative human chorionic gonadotropin
Time frame: The β-hCG levels were assessed on the 1st of treatment
β-hCG level
A quantitative human chorionic gonadotropin
Time frame: The β-hCG levels were assessed on the 11th day of treatment
Complete blood count (CBC)
Complete blood count
Time frame: Assessed on the 1st day of treatment
Alanine Amino Transferase (ALT)
Liver enzyme
Time frame: Assessed on the 1st and 11th day of treatment
Aspartate aminotransferase (AST)
Liver enzyme
Time frame: Assessed on the 1st and 11th day of treatment
Serum creatinine
Renal function test
Time frame: Assessed on the 1st and 11th day of treatment
Blood urea
Renal function test
Time frame: Assessed on the 1st and 11th day of treatment
Complete blood count (CBC)
Complete blood count
Time frame: Assessed on the 11th day of treatment
Alanine Amino Transferase (ALT)
Liver enzyme
Time frame: Assessed on the 11th day of treatment
Aspartate aminotransferase (AST)
Liver enzyme
Time frame: Assessed on the 11th day of treatment
Serum creatinine
Renal function test
Time frame: Assessed on the 11th day of treatment
Blood urea
Renal function test
Time frame: Assessed on the 11th day of treatment
Plan to share: Yes — Table Statistical analysis Master sheet raw data (excel sheet)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: the data will become available after one month from the approval and will be available for three months
Access criteria: you can send a Data request email to Dr: Mohamed at drno99@yahoo.com
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole