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Completed

NCT Number: NCT03972917

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

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.

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Key information

Conditions

Myoma Dysmenorrhea Endometrial Hyperplasia Endometrium Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menstruation Disturbances Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Bleeding Heavy Uterine Bleeding, Dysfunctional Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasonographic examination

Diagnostic Test

Evaluation of endometrial thickness; myoma size and volume

Primary outcomes

  1. Dysmenhorrea (VAS score)

    Time frame: 12 months

  2. Endometrial thickess (mm)

    Time frame: 12 months

  3. Myoma's diameter (mm)

    Time frame: 12 months

Secondary outcomes

  1. Live birth rate (LBR)

    Time frame: 12 months

    Live birth rate if women conceived spontaneously or through ARTs after treatment

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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