Clinical trial · Observational
Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns
NCT03972917CI-TRIAL-00063287completedClinicalTrials.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)
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysmenorrhea | — | UNRESOLVED | — |
| Endometrium Hyperplasia | — | UNRESOLVED | — |
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Bleeding, Dysfunctional | — | UNRESOLVED | — |
| Uterine Bleeding Heavy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transvaginal ultrasonographic examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ulipristal acetate based therapy
- description
- Fertile women under ulipristal acetate treatment
- interventionNames
- Diagnostic Test: Transvaginal ultrasonographic examination
Primary outcomes (3)
- measure
- Dysmenhorrea (VAS score)
- timeFrame
- 12 months
- measure
- Endometrial thickess (mm)
- timeFrame
- 12 months
- measure
- Myoma's diameter (mm)
- timeFrame
- 12 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * number of myomas from 1 to 4 * heavy menstrual bleeding * conservative treatment request Exclusion Criteria: * concurrent endometrial pathology * post-menopausal status * hepatic pathology * endocrine or metabolic disorders
References
Publications (0)
Data not yet available
No reference posted for this study.