Evaluation of Different Doses of Letrozole in Ectopic Pregnancy (letrezole)
15. januar 2022 opdateret af: Mohamed Ali Alabiad, MD, Zagazig University
Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sharkia
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Zagazig, Sharkia, Egypten, 14150
- Mohamed ALI Alabiad
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 35 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group I (GI)
Patients who were undergoing surgical treatment
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laparoscopic salpingectomy
|
|
Eksperimentel: low dose letrozole group II (GII)
patients who were medically treated with 5 mg of letrozole
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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)
Andre navne:
|
|
Eksperimentel: High dose letrozole group (GIII)
patients who were medically treated with 10 mg of letrozole using
|
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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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β-hCG level
Tidsramme: The β-hCG levels were assessed on the 1st of treatment
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A quantitative human chorionic gonadotropin
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The β-hCG levels were assessed on the 1st of treatment
|
|
β-hCG level
Tidsramme: The β-hCG levels were assessed on the 11th day of treatment
|
A quantitative human chorionic gonadotropin
|
The β-hCG levels were assessed on the 11th day of treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete blood count (CBC)
Tidsramme: Assessed on the 1st day of treatment
|
Complete blood count
|
Assessed on the 1st day of treatment
|
|
Alanine Amino Transferase (ALT)
Tidsramme: Assessed on the 1st and 11th day of treatment
|
Liver enzyme
|
Assessed on the 1st and 11th day of treatment
|
|
Aspartate aminotransferase (AST)
Tidsramme: Assessed on the 1st and 11th day of treatment
|
Liver enzyme
|
Assessed on the 1st and 11th day of treatment
|
|
Serum creatinine
Tidsramme: Assessed on the 1st and 11th day of treatment
|
Renal function test
|
Assessed on the 1st and 11th day of treatment
|
|
Blood urea
Tidsramme: Assessed on the 1st and 11th day of treatment
|
Renal function test
|
Assessed on the 1st and 11th day of treatment
|
|
Complete blood count (CBC)
Tidsramme: Assessed on the 11th day of treatment
|
Complete blood count
|
Assessed on the 11th day of treatment
|
|
Alanine Amino Transferase (ALT)
Tidsramme: Assessed on the 11th day of treatment
|
Liver enzyme
|
Assessed on the 11th day of treatment
|
|
Aspartate aminotransferase (AST)
Tidsramme: Assessed on the 11th day of treatment
|
Liver enzyme
|
Assessed on the 11th day of treatment
|
|
Serum creatinine
Tidsramme: Assessed on the 11th day of treatment
|
Renal function test
|
Assessed on the 11th day of treatment
|
|
Blood urea
Tidsramme: Assessed on the 11th day of treatment
|
Renal function test
|
Assessed on the 11th day of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ahmed I Heraiz, MD, Zagazig University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2020
Primær færdiggørelse (Faktiske)
20. november 2021
Studieafslutning (Faktiske)
1. januar 2022
Datoer for studieregistrering
Først indsendt
4. januar 2022
Først indsendt, der opfyldte QC-kriterier
15. januar 2022
Først opslået (Faktiske)
20. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Arytmier, hjerte
- Sygdom i hjertets ledningssystem
- Graviditetskomplikationer
- Graviditet, ektopisk
- Hjertekomplekser, for tidligt
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Hormoner, hormonsubstitutter og hormonantagonister
- Hormonantagonister
- Aromatasehæmmere
- Steroidsyntesehæmmere
- Østrogenantagonister
- Letrozol
Andre undersøgelses-id-numre
- LETROZOLE ON ECTOPIC PREGNANCY
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Table Statistical analysis Master sheet raw data (excel sheet)
IPD-delingstidsramme
the data will become available after one month from the approval and will be available for three months
IPD-delingsadgangskriterier
you can send a Data request email to Dr: Mohamed at drno99@yahoo.com
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Studiedata/dokumenter
-
Studieprotokol
Oplysningskommentarer: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
Statistisk analyseplan
Informations-id: drno99@yahoo.comOplysningskommentarer: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
Formular til informeret samtykke
Oplysningskommentarer: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
Individuelt deltagerdatasæt
Oplysningskommentarer: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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