Clinical trial · Interventional
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.
NCT04576039CI-TRIAL-00047472completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cyst | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| saline infusion sonography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- presenting with thickened endometruim
- 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.
- interventionNames
- Diagnostic Test: saline infusion sonography
Primary outcomes (1)
- measure
- ultrasonographic morphology of the endometrium at saline infusion sonography
- timeFrame
- 1 week
- description
- thickness and appearance of the endometrium
Secondary outcomes (1)
- measure
- diagnostic ability to exclude intrauterine pathology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.