Clinical trial · Interventional
Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma
- 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)
The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.
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
- Womens will be treated with 5 mg/day of oral ulipristal acetate for 3 months
- interventionNames
- Drug: ulipristal acetate
- type
- ACTIVE_COMPARATOR
- label
- Leuprolile acetate
- description
- women will be treated with 1 IM injection of leuprolide acetate 11,25 mg in in the luteal phase
- interventionNames
- Drug: Leuprolide acetate
Primary outcomes (1)
- measure
- Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC)
- timeFrame
- 90 days after the beginning of the treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: submucosal leiomyoma, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain. Exclusion Criteria: intramural or subserosal leiomyomas, endometrial hyperplasia with atypia, history of uterine surgery
References
Publications (0)
Data not yet available