Clinical trial · Interventional
Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas
Advantages of Ulipristal Acetate for the Preoperative Treatment of Hypoechoic Cellular Leiomyomas
- 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)
Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.
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 |
|---|---|---|---|
| Fibroid | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
| ulipristal acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ulipristal acetate
- description
- women will be treated with an oral dose of ulipristal acetate 5 mg/day for 3 months
- interventionNames
- Drug: ulipristal acetate
- type
- ACTIVE_COMPARATOR
- label
- Leuprolile acetate
- description
- Women will be treated with an intramuscular (IM) injection of leuprolide acetate 11.25 mg in the luteal phase
- interventionNames
- Drug: Leuprolide acetate
Primary outcomes (1)
- measure
- Operative time (minutes)
- timeFrame
- At the time of skin closure at the end of the myomectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * hypoechoic uterine leiomyoma (echogenicity \<3), * intramural leiomyomas with an ultrasonographic size \<20 cm but \>4cm, * indication to surgery (symptoms of menometrorrhagia, * menstrual disorder, * infertility, * pelvic pain or pelvic pressure Exclusion Criteria: * submucosal leiomyoma, * endometrial hyperplasia with atypia, * history of uterine surgery
References
Publications (0)
Data not yet available