UA Versus UAE in Treatment of Fibroids

NCT04832906 | Completed Phase 4 DMC

• 1 other identifier: FMASU M D 71/2019
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Abnormal uterine bleeding (AUB); Benign gynecologic conditions; Ulipristal acetate; Uterine artery embolization

Outcome Measures

Primary Outcomes (1)

• Decline in dominant fibroid volume (in cubic centimeters).

  measured by transvaginal ultrasound.

  3 months

Secondary Outcomes (4)

• Relief of abnormal uterine bleeding.

  3 months

• Relief of pelvic pain.

  3 months

• Relief of pelvic pressure symptoms.

  3 months

• Adverse effects.

  6 months

Study Arms (2)

Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35)

ACTIVE COMPARATOR

Patients within this group received oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).

Drug: Ulipristal Oral Tablet

Group B "Uterine artery embolization (UAE) group" (n=35)

ACTIVE COMPARATOR

Patients within this group underwent bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles was 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. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization.

Procedure: Uterine artery embolization

Interventions

Ulipristal Oral Tablet DRUG

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.

Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35)

Uterine artery embolization PROCEDURE

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.

Group B "Uterine artery embolization (UAE) group" (n=35)

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Their age should range from 35 to 50 years.
• Their body mass index (BMI) should range from 18 to 35 Kg/m2.
• The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
• The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
• They should not be seeking future fertility.
• They should be refusing any surgical intervention whether myomectomy or hysterectomy.

You may not qualify if:

• Post-menopausal status or premature ovarian failure.
• Type 0, 1 and 7 uterine fibroids according to FIGO classification.
• Previous myomectomy or any uterine surgery.
• Previous or ongoing hormonal treatment.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Abbassia, 11517, Egypt

Location

MeSH Terms

Conditions

Leiomyoma; Metrorrhagia

Interventions

ulipristal; Uterine Artery Embolization

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

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: March 13, 2019
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)