The Aromatase Inhibitor and Gnrh Antagonist Versus Methot... | NCT04308343

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

NCT04308343

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 16, 2020Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Ectopic Pregnancy

Interventions

Methotrexate
Letrozole
cetrotide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2020Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 11, 2020

First Posted Date

Mar 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2020

Last Update Posted Date

Mar 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to :

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Methotrexate group	Active Comparator	Drug: Methotrexate
Letrozole group	Active Comparator	Drug: Letrozole
Gonadotropins releasing hormone antagonist group	Active Comparator	Drug: cetrotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug	Drugs to treat undisturbed ectopic pregnancies	Methotrexate group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 .		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali Saber Ali, M.Sc	Contact	01095567589		kenous87@yahoo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008727	Methotrexate
D000077289	Letrozole
C062876	cetrorelix

Ancestor Terms

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided