PGL4001 Versus GnRH-agonist in Uterine Myomas

Summary

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Timeline

Start

2008-08

Primary completion

2010-01

Completion

2010-06

Outcome

Met primary endpoint

paper Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding PMID 22296076 ↗

registry B (PGL4001 10mg) vs C (GnRH-agonist); p <0.001; Median Difference (Net) -29.9 (95% CI -42.0 to -16.6) NCT00740831 ↗

Publications

• Results Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Leuprolide	Other / unclassified	3.75 mg	Intramuscular
Subject	Ulipristal Acetate	Unknown	5 mg	Oral
Subject	Ulipristal Acetate	Unknown	10 mg	Oral

Indications