PGL4001 Versus Placebo in Uterine Myomas

Summary

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, 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

2008-10

Primary completion

2010-03

Completion

2010-08

Outcome

Met primary endpoint

registry A (PGL4001 5mg) vs C (Placebo); p <0.001; Difference in proportions 72.7 (95% CI 55.1 to 83.2) NCT00755755 ↗

registry A (PGL4001 5mg) vs C (Placebo); p = 0.002; Median Difference (Final Values) -22.6 (95% CI -36.1 to -8.2) NCT00755755 ↗

Publications

• Results Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182.
• Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014 Mar;29(3):480-9. doi: 10.1093/humrep/det467. Epub 2014 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulipristal Acetate	Unknown	5 mg	Oral
Subject	Ulipristal Acetate	Unknown	10 mg	Oral
Background	Iron Sulfate	Small molecule	80 mg	Oral

Indications