Clinical trial · Interventional
Ulipristal Acetate in Symptomatic Uterine Fibroid
The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
NCT04132349CI-TRIAL-00044618terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Ulipristal Acetate was recalled
Summary
Brief summary (as posted)
This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heavy Menstrual Bleeding | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ulipristal Acetate 5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ullipristal Acetate
- description
- Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months
- interventionNames
- Drug: Ulipristal Acetate 5 mg
Primary outcomes (1)
- measure
- Amenorrhea
- timeFrame
- from first dose to the end of 3 consecutive months of treatment course
- description
- Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.
Secondary outcomes (7)
- measure
- time from treatment to amenorrhea
- timeFrame
- from first dose to the end of 3 consecutive months of treatment course
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-48 * Regular cycle of 22-35 days interval and FSH \<=20 mUI/mL. * \>=1 uterine fibroid of 3\<= d \< 10cm (regardless of location), diagnosed by transvaginal ultrasound. * Heavy menstrual bleeding (blood loss \>80ml/cycle). * Uterine size \< 16 weeks of GA on clinical examination. * Agree to participate in the study. Exclusion Criteria: * Previous or current treatment of uterus, cervix, ovarian or breast cancer. * Previous endometrial ablation or uterine artery embolization. * Abnormal PAP's smear result within 12 months prior to recruitment. * Endometrial hyperplasia within 6 months prior to recruitment. * Uterine polyp \>2cm. * Ovarian cysts 4cm diagnosed by transvaginal ultrasound. * Severe anemia (Hb 6 g/dl) or indication for blood transfusion. * Coagulation disorder indicated for treatment. * Increased liver enzyme level of twofold or more than normal upper limit. * Previous use of SPRM. * Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment. * Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid
References
Publications (0)
Data not yet available
No reference posted for this study.