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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometrial Hyperplasia
• Endometrium Hyperplasia
• Hemorrhage
• Hyperplasia
• Leiomyoma
• Metrorrhagia
• Myoma
• Uterine Bleeding Heavy
• Uterine Bleeding, Dysfunctional
• Uterine Hemorrhage

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