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

NCT ID: NCT03972917

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myoma Uterine Bleeding, Dysfunctional Uterine Bleeding Heavy Dysmenorrhea Endometrium Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ulipristal acetate based therapy

Fertile women under ulipristal acetate treatment

Transvaginal ultrasonographic examination

Intervention Type DIAGNOSTIC_TEST

Evaluation of endometrial thickness; myoma size and volume

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transvaginal ultrasonographic examination

Evaluation of endometrial thickness; myoma size and volume

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Pasquale De Franciscis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gaetano Riemma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N.595

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adenomyosis and Ulipristal Acetate
NCT02587000 COMPLETED PHASE2
Esmya Versus Surgery Before IVF/ICSI
NCT04028986 ACTIVE_NOT_RECRUITING