Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

University of Campania Luigi Vanvitelli89 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myoma Uterine Bleeding, Dysfunctional Uterine Bleeding Heavy Dysmenorrhea Endometrium Hyperplasia

Interventions

Transvaginal ultrasonographic examinationDIAGNOSTIC_TEST

Evaluation of endometrial thickness; myoma size and volume

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Naples, Italy

Outcomes

Primary Outcomes

Dysmenhorrea (VAS score)

Time frame: 12 months

Endometrial thickess (mm)

Time frame: 12 months

Myoma's diameter (mm)

Time frame: 12 months

Secondary Outcomes

Live birth rate (LBR)

Live birth rate if women conceived spontaneously or through ARTs after treatment

Time frame: 12 months

Data from ClinicalTrials.gov

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