Clinical trial · Interventional
Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation
Ulipristal Acetate Versus GnRH Analogue for Myometrial Preservation in Patients With Submucosal Uterine Leiomyoma G2
- 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)
Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment
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 2 courses of 3 months each
- interventionNames
- Drug: ulipristal acetate
- type
- ACTIVE_COMPARATOR
- label
- Leuprolile acetate
- description
- Women will be treated with an injection IM on leuprolide acetate 11,25 in the luteal phase repeated 3 months later
- interventionNames
- Drug: Leuprolide acetate
Primary outcomes (1)
- measure
- Proportion of restored uterine cavity 1 year after enrollment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: G2 submucosal leiomyoma \<3 cm, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain Exclusion Criteria: submucosal leyomyoma other than G2 or greater than 3 cm, intramural or subserosal leiomyomas endometrial hyperplasia with atypia history of uterine surgery
References
Publications (0)
Data not yet available