9 completed, 1 unknown. 6 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 2 | Completed 2 |
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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 |
|---|---|---|---|---|---|---|
| Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting Uterine Fibroids | Completed | PregLem SA | 1527 | 2015-12-22 | 2025-09-02 | |
| 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 |
| PGL2001 Proof of Concept Study in Symptomatic Endometriosis PGL2001 + Primolut-Nor 5, Placebo + Primolut-Nor 5 - Endometriosis | Phase 2 | Completed | PregLem SA | 162 | 2012-06-01 | 2014-06-03 |
| PGL5001 Proof of Concept Study in Inflammatory Endometriosis PGL5001, Placebo - Endometriosis | Phase 2 | Completed | PregLem SA | 24 | 2012-06-01 | 2014-06-03 |
| A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids Uterine Fibroids | Unknown | PregLem SA | 1500 | 2012-05-01 | 2015-01-27 | |
| 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 (6) · Endometriosis (2)
ulipristal acetate (5) · Progestins (2) · Gonadotropin-Releasing Hormone (1) · Iron (1) · Leuprolide (1) · bentamapimod (1) · ulipristal (1)
Poland (8) · Belgium (6) · Spain (6) · Austria (5) · Hungary (5) · Romania (5) · France (4) · Germany (4) · Italy (4) · Czechia (3) · United Kingdom (3) · Latvia (2) · Lithuania (2) · Netherlands (2) · Portugal (2)
Dr Elke Bestel (2) · Elke Bestel, Dr (1) · Elke Bestel, MD (1) · Jaime Oliver, MD (1) · Pablo Arriagada (1) · Pablo Arrigada, MD (1)
PMID 24630081, PMID 22296075, PMID 22296076, PMID 24457604, PMID 25542821, PMID 26477496, PMID 28676450