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Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Primary Purpose

Uterine Fibroid, Endometrial Cyst

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

saline infusion sonography

About this trial

This is an interventional diagnostic trial for Uterine Fibroid

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women with thickened endometrium on ultrasound (defined as double endometrium thickness of ≥10mm) at the end of their treatment with ulipristalacetate.
Normal double endometrium thickness before the use of ESMYA (<10mm)
BMI >18 - < 30

Exclusion Criteria:

Known type 0 or 1 fibroids
Known intrauterine pathology

Sites / Locations

Universitair Ziekenhuis UZBrussel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

presenting with thickened endometruim

Arm Description

women presenting with thickened endometrium after the use of ulipristalacetate will undergo a saline infusion in the uterus and immediate ultrasonographic control to visualise the morphology of the endometrium.

Outcomes

Primary Outcome Measures

ultrasonographic morphology of the endometrium at saline infusion sonography

thickness and appearance of the endometrium

Secondary Outcome Measures

diagnostic ability to exclude intrauterine pathology

presence yes or no of intra uterine pathology as polyps or fibroids

Full Information

NCT ID

NCT04576039

First Posted

September 29, 2020

Last Updated

September 29, 2020

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04576039

Brief Title

Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

Official Title

Ultrasonographic Appearance of the Endometrium After Saline Infusion in Women Presenting With a Thickened Endometrium After the Use of Ulipristalacetate.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

If endometrial thickening is visualised (>10mm) after the use of ulipristalacetate in case of medical treatment for uterine fibroids a saline infusion and sonographic examination will be performed to evaluate the endometrium and exclude intra-uterine pathology.

Detailed Description

When ultrasonographic examination during follow up of a treatment with ulipristalacetate shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of ulipristalacetate users and is completely benign), a saline infusion can help to exclude pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be seen. This study was set up to describe how the endometrial changes after Esmya use appear on saline infusion sonography. This study can help to recognize ultrasonographic images in women presenting with thickened endometrium after Ulipristalacetate use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroid, Endometrial Cyst

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

presenting with thickened endometruim

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

saline infusion sonography

Intervention Description

Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.

Primary Outcome Measure Information:

Title

ultrasonographic morphology of the endometrium at saline infusion sonography

Description

thickness and appearance of the endometrium

Time Frame

1 week

Secondary Outcome Measure Information:

Title

diagnostic ability to exclude intrauterine pathology

Description

presence yes or no of intra uterine pathology as polyps or fibroids

Time Frame

1week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with thickened endometrium on ultrasound (defined as double endometrium thickness of ≥10mm) at the end of their treatment with ulipristalacetate. Normal double endometrium thickness before the use of ESMYA (<10mm) BMI >18 - < 30 Exclusion Criteria: Known type 0 or 1 fibroids Known intrauterine pathology

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Degreef, PhD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Study Chair

Facility Information:

Facility Name

Universitair Ziekenhuis UZBrussel

City

Jette

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

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