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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Uterine Bleeding, Dysfunctional; Dysmenorrhea; Uterine Bleeding Heavy; Endometrium Hyperplasia; Myoma

Treatments: Diagnostic Test: Transvaginal ultrasonographic examination

Study type: Observational

Funder types: Other

Identifiers

NCT03972917

N.595

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

89 participants in 1 patient group

ulipristal acetate based therapy

Description:

Fertile women under ulipristal acetate treatment

Treatment:

Diagnostic Test: Transvaginal ultrasonographic examination