Clinical trial · Interventional
Ulipristal Acetate 10 mg and Asisted Reproduction
Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
NCT02425878CI-TRIAL-00047635terminatedPhase 3ClinicalTrials.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): Lack of availibility of eligible subjects
Summary
Brief summary (as posted)
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
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 |
|---|---|---|---|
| Intramural Fibroids | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Ulipristal Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
- interventionNames
- Drug: Ulipristal Acetate
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- increase in the rate of clinical pregnancy
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Patients\> 18 and \<50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas\> 2 cm and \<5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery Exclusion Criteria: History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study
References
Publications (0)
Data not yet available
No reference posted for this study.