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

NCT03972917 | Completed

• 1 other identifier: N.595
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ulipristal acetate; myoma; leiomyoma; endometrial patterns; symptomatology

Outcome Measures

Primary Outcomes (3)

• Dysmenhorrea (VAS score)

  12 months

• Endometrial thickess (mm)

  12 months

• Myoma's diameter (mm)

  12 months

Secondary Outcomes (1)

• Live birth rate (LBR)

  12 months

Study Arms (1)

ulipristal acetate based therapy

Fertile women under ulipristal acetate treatment

Diagnostic Test: Transvaginal ultrasonographic examination

Interventions

Transvaginal ultrasonographic examination DIAGNOSTIC_TEST

Evaluation of endometrial thickness; myoma size and volume

ulipristal acetate based therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Italian fertile women who are eligible for conservative treatment for uterine fibroids

You may qualify if:

• number of myomas from 1 to 4
• heavy menstrual bleeding
• conservative treatment request

You may not qualify if:

• concurrent endometrial pathology
• post-menopausal status
• hepatic pathology
• endocrine or metabolic disorders

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

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

Naples, Italy

Location

MeSH Terms

Conditions

Myoma; Metrorrhagia; Dysmenorrhea; Endometrial Hyperplasia; Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gaetano Riemma, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 4, 2019
• Study Start: November 1, 2018
• Primary Completion: July 10, 2021
• Study Completion: September 21, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

IT (1)