6 completed. 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata Ulipristal Acetate - open label - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 64 | 2012-07-01 | 2016-01-08 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata PGL4001 5 mg, PGL4001 10 mg - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 451 | 2012-06-01 | 2019-09-04 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) PGL4001, placebo, drug free period, PGL4001, progestin, drug free period - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 132 | 2011-01-01 | 2016-01-13 |
| PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata PGL4001, placebo, PGL4001, progestin - Uterine Fibroids | Phase 3 | Completed | PregLem SA | 209 | 2010-07-01 | 2016-01-15 |
| PGL4001 Versus Placebo in Uterine Myomas PGL4001 (ulipristal) and iron, PGL4001 matching placebo and iron - Uterine Myomas | Phase 3 | Completed | PregLem SA | 241 | 2008-10-01 | 2012-12-13 |
| PGL4001 Versus GnRH-agonist in Uterine Myomas PGL4001, leuprorelin - Uterine Myomas | Phase 3 | Completed | PregLem SA | 301 | 2008-08-01 | 2012-12-17 |
Leiomyoma (4)
ulipristal acetate (5) · Progestins (2) · Gonadotropin-Releasing Hormone (1) · Iron (1) · Leuprolide (1) · ulipristal (1)
Belgium (5) · Austria (4) · Poland (4) · Spain (4) · Czechia (2) · France (2) · Germany (2) · Hungary (2) · Italy (2) · Romania (2) · Ukraine (2) · India (1) · Israel (1) · Latvia (1) · Lithuania (1)
Dr Elke Bestel (2) · Elke Bestel, Dr (1) · Pablo Arrigada, MD (1)
PMID 24630081, PMID 22296075, PMID 22296076, PMID 24457604, PMID 25542821, PMID 26477496