Clinical trial · Interventional
UA Versus UAE in Treatment of Fibroids
Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal Oral Tablet | Drug | — | UNRESOLVED |
| Uterine artery embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35)
- description
- 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).
- interventionNames
- Drug: Ulipristal Oral Tablet
- type
- ACTIVE_COMPARATOR
- label
- Group B "Uterine artery embolization (UAE) group" (n=35)
- description
- 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.
- interventionNames
- Procedure: Uterine artery embolization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available