drugset / Trial / NCT00755755
PGL4001 Versus Placebo in Uterine Myomas
RandomizedParallel-groupDouble-blindTreatment
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
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 |