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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% 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.

SUBMITTER: Nieman LK 

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

REPOSITORIES: biostudies-literature

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

Nieman Lynnette K LK   Blocker Wendy W   Nansel Tonja T   Mahoney Sheila S   Reynolds James J   Blithe Diana D   Wesley Robert R   Armstrong Alicia A  

Fertility and sterility 20101105 2


<h4>Objective</h4>To evaluate the efficacy and tolerability of the P receptor modulator CDB-2914 (Ulipristal, CDB).<h4>Design</h4>Randomized, placebo-controlled double-blind clinical trial.<h4>Setting</h4>Clinical research center.<h4>Patient(s)</h4>Premenopausal women with symptomatic uterine fibroids.<h4>Intervention(s)</h4>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 ra  ...[more]

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