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UA Versus UAE in Treatment of Fibroids

NCT04832906 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-04-06

No results posted yet for this study

Summary

Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization.

Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University.

Patients: Women with symptomatic uterine fibroids.

Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.

Conditions

  • Uterine Fibroid

Interventions

DRUG

Ulipristal Oral Tablet

A selective progesterone receptor modulator (SPRM), as a medical line of treatment for uterine fibroids. Due to its selective anti-proliferative and pro-apoptotic action, Ulipristal Acetate (UA) is assumed to be effective in reducing abnormal uterine bleeding (AUB) and fibroid size.

PROCEDURE

Uterine artery embolization

Selective embolization of uterine arteries bilaterally, using polyvinyl alcohol (PVA) particles administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2021-03-13
Completion
2021-03-13

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832906 on ClinicalTrials.gov