UA Versus UAE in Treatment of Fibroids

• Status: Completed
• Trial end date: 2021-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams Maternity Hospital
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.