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

ABSTRACT:

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

SUBMITTER: Nieman LK 

PROVIDER: S-EPMC4180231 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature