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NCT03972917 Clinical Trial

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

Dysmenorrhea Clinical Trial

Official title:
Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03972917
Other study ID # N.595
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date September 21, 2021

Study information
Verified date January 2023
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date September 21, 2021
Est. primary completion date July 10, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Transvaginal ultrasonographic examination
Evaluation of endometrial thickness; myoma size and volume

Locations
Country Name City State
Italy Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli" Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dysmenhorrea (VAS score) 12 months
Primary Endometrial thickess (mm) 12 months
Primary Myoma's diameter (mm) 12 months
Secondary Live birth rate (LBR) Live birth rate if women conceived spontaneously or through ARTs after treatment 12 months
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