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The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308343
Recruitment Status : Unknown
Verified March 2020 by Ali saber ali, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ali saber ali, Assiut University

Brief Summary:

The aim of this study is to :

  1. Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
  2. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

Condition or disease Intervention/treatment Phase
Ectopic Pregnancy Drug: Methotrexate Drug: Letrozole Drug: cetrotide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Methotrexate group Drug: Methotrexate
Drugs to treat undisturbed ectopic pregnancies

Active Comparator: Letrozole group Drug: Letrozole
Drugs to treat undisturbed ectopic pregnancies

Active Comparator: Gonadotropins releasing hormone antagonist group Drug: cetrotide
Drugs to treat undisturbed ectopic pregnancies




Primary Outcome Measures :
  1. determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated . [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have undisturbed ectopic pregnancy .Who are:

    1. have no significant pain
    2. have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat
    3. have a serum human chorionic gonadotropins level less than 1,500 IU/litre
    4. do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .

Exclusion Criteria:

  1. An undisturbed ectopic pregnancy and significant pain
  2. An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
  3. An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
  4. An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
  5. intrauterine pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308343


Contacts
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Contact: Ali Saber Ali, M.Sc 01095567589 kenous87@yahoo.com

Sponsors and Collaborators
Assiut University
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Responsible Party: Ali saber ali, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04308343    
Other Study ID Numbers: Aromatase inhibitor in ectopic
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy, Ectopic
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Pregnancy Complications
Methotrexate
Letrozole
Cetrorelix
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists