Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04576039

Enrollment

Registered

2020-10-05

Start date

2019-01-01

Completion date

2020-09-30

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cyst, Uterine Fibroid

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.

Interventions

DIAGNOSTIC_TESTsaline infusion sonography

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ultrasonographic morphology of the endometrium at saline infusion sonography	1 week	thickness and appearance of the endometrium

Secondary

Measure	Time frame	Description
diagnostic ability to exclude intrauterine pathology	1week	presence yes or no of intra uterine pathology as polyps or fibroids

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026