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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03972917

Enrollment

Registered

2019-06-04

Start date

2018-11-01

Completion date

2021-09-21

Last updated

2023-01-18

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

Conditions

Dysmenorrhea, Endometrium Hyperplasia, Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy

Keywords

ulipristal acetate, myoma, leiomyoma, endometrial patterns, symptomatology

Brief summary

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.

Interventions

DIAGNOSTIC_TESTTransvaginal ultrasonographic examination

Evaluation of endometrial thickness; myoma size and volume

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dysmenhorrea (VAS score)	12 months
Endometrial thickess (mm)	12 months
Myoma's diameter (mm)	12 months

Secondary

Measure	Time frame	Description
Live birth rate (LBR)	12 months	Live birth rate if women conceived spontaneously or through ARTs after treatment

Countries

Italy

Outcome results

None listed

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