- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07624903
Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Ectopic pregnancy (EP) was defined as the implantation of fertilized ovum anywhere other than the endometrial uterine cavity and accounts for 1-2% of all pregnancies , but its prevalence after assisted reproduction trials was found to be higher. Tubal EP (TEP) is the commonest and is associated with a high risk of rupture leading to extensive bleeding and complicated surgery,so it represents asignificant threat to maternal life . Management of Ectopic pregnancy is still a source of debate where surgical management; salpingotomy or salpingectomy is curative but insufficient removal of the ectopic tissue may occur with salpingotomy causing persistent trophoblast tisseue . Other sites of ectopic pregnancy including, cervix, myometrium, ovary, abdominal cavity.
Heterotopic pregnancy refers to coexistence of an intrauterine pregnancy with an ectopic pregnancy in any these locations.
The classic clinical triad of ectopic pregnancy is pain, amenorrhea, and vaginal bleeding; unfortunately, only about 50% of patients present with all 3 symptoms. About 40-50% of patients with an ectopic pregnancy present with vaginal bleeding, 50% have a palpable adnexal mass, and 75% may have abdominal tenderness.The availability of transvaginal ultrasonography (TVU) and serum βhuman chorionic gonadotropin (βhCG) assay allowed early diagnosis of EP and paved the way for medical treatment of EP, but within certain conditions .
A standard treatment option for many patients of ectopic pregnancy , Single- and multi-dose systemic methotrexate (MTX) protocols are used most commonly, with no difference in success rate. Given its simplicity and low complication rate, the singledose protocol is used more widely throughout the world . The single dose regimen consists of an intramuscular injection (IM) of MTX (50 mg/m2 of body surface area), with administration of additional doses at weekly intervals in patients with an inadequate response. Repeated injections are permitted every 7 days for up to 3 doses second dose is needed in 20 % or more of patients, while less than 1 % of patients require 3 or more doses. The single dose regimen is associated with fewer side effects as compared to other regimens . Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis . By inhibiting dihydrofolate reductase, methotrexate interrupts trophoblast proliferation and induces abortion. Methotrexate is as effective as salpingostomy for ectopic pregnancy and does not appear to affect future fertility .However, no dose of MTX is immune against side effects even small doses . Multiple studies documented the safety and efficacy of single-dose methotrexate (SD-MTX) as a medical treatment for EP that in carefully selected cases might be an effective alternative to surgery . However, the efficacy of SD-MTX is recently questionable and multiple studies tried to evaluate the efficacy of two-dose versus SD-MTX for the medical management of EP. Third-generation aromatase inhibitors such as letrozole are well established in clinical use for suppressing estrogen production in women with breast cancer. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use .This group of aromatase inhibitors including, letrozole, has been shown to Successfully block estrogen production in reproductive age.
In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors. It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancyPrevious study evaluate the effective role of adding letrozole to methotrexate in management of tubal ectopic pregnancy. our study will aim to compare between the effect of methotrexate versus letrozoe in management of ectopic pregnancy.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Aya Fekry Saad Bahnasy, Obstetrics&Gynecology resident
- Telefonnummer: +201092178164
- E-Mail: ayafekry772@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Mostafa Farag Ellakany, Obstetrics&Gynecology Lecturer
- Telefonnummer: +2010116083210
- E-Mail: mfe_2014@yahoo.com
Studienorte
-
-
Kafr el-Sheikh Governorate
-
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Ägypten, 33511
- Kafr El-Sheikh University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Confirmed ectopic pregnancy on trans vaginal ultrasound
- Age between 20 and 35 years
- A β-hCG levels < 3000 Iu/ L
- The average diameter of the adnexal mass ≤3.5 cm
- Stable hemodynamic condition
Exclusion Criteria:
- Presence of fetal heart pulsation
- Heterotopic pregnancy
- Presence of significant abdominal pain
- history of allergic reactions to MTX or letrozole
- Any known liver disorder or abnormal liver enzyme levels (AST or ALT )
- Any known renal disorder or impaired renal function tests (abnormal creatinine)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Methotrexate
Group 1 : 35 of patients with early undisturbed ectopic pregnancy will receive methotrexate (1mg\kg IM) and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department ., Faculty of Medicine, Kafrelsheikh University Hospitals.
At day 7 If β-hCG decrease >15% than day 4 , β-hCG will be repeated weekly till negative but If β-hCG decrease < 15% than day 4 second dose of methotrexate will be given 50mg/m2 IM and follow up weekly (maximum dose is 4 doses) .
|
Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis
|
|
Aktiver Komparator: Letrozole
Groub 2 : 35 of patients with early undisturbed ectopic pregnancy will receive letrozole (2.5 mg three times daily) for 10 days and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department, Faculty of Medicine, Kafrelsheikh University Hospitals .
Patients who had no success response to letrozole (β-hCG not decreased by 30% after 10 days ) , laparoscopy will be done .
|
Aromatase inhibitors has been shown toSuccessfully block estrogen production In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors.
It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancy
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Resolution of complain
Zeitfenster: β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).
|
follow up by β-hCG on day 4 and day 7 of first dose
|
β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Walid Mamdouh Atallah, OBGYN Professor, Tanta University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Schwangerschaftskomplikationen
- Schwangerschaft, Eileiter
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Azolen
- Nitrile
- Pterins
- Pteridine
- Aminopterin
- Triazoles
- Letrozol
- Methotrexat
- Pharmazeutische Präparate
Andere Studien-ID-Nummern
- Ectopic Pregnancy Manegement
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Methotrexate (drug)
-
University Hospital UlmRekrutierungChronischer totaler Verschluss | Chronischer Totalverschluss der KoronararterieDeutschland
-
Chinese PLA General HospitalUnbekannt
-
Hospital Universitari Vall d'Hebron Research InstituteB.Braun Surgical SAAbgeschlossen
-
Medstar Health Research InstituteAktiv, nicht rekrutierendAtheroskleroseVereinigte Staaten, Deutschland, Zypern, Israel, Schweden, Vereinigtes Königreich, Italien, Griechenland
-
Cardiocentro TicinoUniversity of BernRekrutierungChronisches KoronarsyndromSchweiz
-
Sahlgrenska University HospitalUppsala University; The Swedish Research Council; Swedish Heart Lung Foundation; The Swedish National Registry for Vascular SurgeryAktiv, nicht rekrutierendPeriphere arterielle Verschlusskrankheit | Schaufensterkrankheit | Kritische ExtremitätenischämieSchweden
-
Scitech Produtos Medicos SANoch keine RekrutierungKoronare Herzkrankheit (KHK) | Mehrgefäßkoronare Herzkrankheit | Komplexe Koronarläsionen | Kalkkoronare Arteriosklerose | Ischämische Erkrankung kleiner Gefäße | KoronarstenoseBrasilien
-
Virginia KrausEli Lilly and Company; EndocyteAbgeschlossen
-
Nanfang Hospital of Southern Medical UniversityRekrutierungIschämischer Schlaganfall | WirbelarterienstenoseChina
-
University of Rome Tor VergataAbgeschlossenMedikamentenbeschichteter Ballon | Plaque-Modifikationstechnik | Koronare kalzifizierte LäsionenItalien