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.

• Authors: Lynnette K Nieman, Wendy Blocker, Tonja Nansel, Sheila Mahoney, James Reynolds, Diana Blithe, Robert Wesley, Alicia Armstrong
• Journal: Fertility and sterility (Fertil Steril) Vol. 95 Issue 2 Pg. 767-72.e1-2 (Feb 2011) ISSN: 1556-5653 [Electronic] United States
• PMID: 21055739 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, N.I.H., Intramural)
• Copyright: Published by Elsevier Inc.

Chemical References

• Antineoplastic Agents, Hormonal
• Hormone Antagonists
• Norpregnadienes
• Placebos
• Progesterone
• ulipristal

Topics

• Adult
• Algorithms
• Antineoplastic Agents, Hormonal (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Hormone Antagonists (adverse effects, therapeutic use)
• Humans
• Leiomyoma (drug therapy)
• Middle Aged
• Norpregnadienes (adverse effects, therapeutic use)
• Placebos
• Progesterone (antagonists & inhibitors)
• Treatment Outcome
• Uterine Neoplasms (drug therapy)