Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study  

Oleh:

Nieman, Lynnette K. ; Blocker, Wendy ; Nansel, Tonja R. ; Mahoney, Sean ; Reynolds, James ; Blithe, Diana L. ; Wesley, Robert ; Armstrong, Alicia

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Fertility and Sterility (keterangan: ada di ClinicalKey) vol. 95 no. 02 (Feb. 2011), page 767-772.e2.
Topik: UTERINE FIBROIDS; Selective progestin receptor modulator; ulipristal acetate; fibroids; UFS-QOL

Ketersediaan

Perpustakaan FK Nomor Panggil: F02.K.2011.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

Lihat Detail Induk

Isi artikel

Objective To evaluate the efficacy and tolerability of the P receptor modulator CDB-2914 (Ulipristal, CDB). Design Randomized, placebo-controlled double-blind clinical trial. Setting Clinical research center. Patient(s) Premenopausal women with symptomatic uterine fibroids. Intervention(s) Once-daily oral CDB (10 or 20 mg) or placebo (PLC) for 12 weeks (treatment 1). A second 3-month treatment with CDB (treatment 2) was offered. A computer-generated blocked randomization was used. Main Outcome Measure(s) Magnetic resonance imaging (MRI)-determined total fibroid volume (TFV) change was the primary outcome; amenorrhea and quality of life (QOL) were secondary end points. Result(s) Treatment 1 TFV increased 7% in the PLC group, but decreased 17% and 24% in the CDB10 and CDB20 groups. The TFV decreased further in treatment 2 (-11%). Amenorrhea occurred in 20/26 women taking CDB and none on PLC. Ovulation resumed after CDB. Hemoglobin improved only with CDB (11.9 ± 1.5 to 12.9 ± 1.0 g/dL) as did the Fibroid QOL Questionnaire symptom severity, energy/mood, and concern subscores, and overall QOL scores. The CDB was well tolerated, with no serious adverse events. Adverse events were unchanged during treatments. Conclusion(s) Administration of CDB-2914 for 3–6 months controls bleeding, reduces fibroid size, and improves QOL.

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