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Obstetrics & Gynecology 2008;111:1129-1136
© 2008 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

CDB-2914 for Uterine Leiomyomata Treatment

A Randomized Controlled Trial

Eric D. Levens, MD1, Clariss Potlog-Nahari, MD1, Alicia Y. Armstrong, MD1, Robert Wesley, PhD2, Ahalya Premkumar, MD3, Diana L. Blithe, PhD4, Wendy Blocker, MSN1 and Lynnette K. Nieman, MD1

From the 1Reproductive Biology and Medicine Branch, National Institute of Child Health and Human Development; 2Department of Biostatistics Services, Warren G. Magnuson Clinical Center; 3Diagnostic Radiology Department, Warren G. Magnuson Clinical Center; and 4Contraception and Reproductive Health Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

OBJECTIVE: To evaluate whether 3-month administration of CDB-2914, a selective progesterone receptor modulator, reduces leiomyoma size and symptoms.

METHODS: Premenopausal women with symptomatic uterine leiomyomata were randomly assigned to CDB-2914 at 10 mg (T1) or 20 mg (T2) daily or to placebo (PLC) for 3 cycles or 90–102 days if no menses occurred. The primary outcome was leiomyoma volume change determined by magnetic resonance imaging at study entry and within 2 weeks of hysterectomy. Secondary outcomes included the proportion of amenorrhea, change in hemoglobin and hematocrit, ovulation inhibition, and quality-of-life assessment.

RESULTS: Twenty-two patients were allocated, and 18 completed the trial. Age and body mass index were similar among groups. Leiomyoma volume was significantly reduced with CDB-2914 administration (PLC 6%; CDB-2914 –29%; P=.01), decreasing 36% and 21% in the T1 and T2 groups, respectively. During treatment, hemoglobin was unchanged, and the median estradiol was greater than 50 pg/mL in all groups. CDB-2914 eliminated menstrual bleeding and inhibited ovulation (% ovulatory cycles: CDB-2914, 20%; PLC, 83%; P=.001). CDB-2914 improved the concern scores of the uterine leiomyoma symptom quality-of-life subscale (P=.04). One CDB-2914 woman developed endometrial cystic hyperplasia without evidence of atypia. No serious adverse events were reported.

CONCLUSION: Compared with PLC, CDB-2914 significantly reduced leiomyoma volume after three cycles, or 90–102 days. CDB-2914 treatment resulted in improvements in the concern subscale of the Uterine Fibroid Symptom Quality of Life assessment. In this small study, CDB-2914 was well-tolerated without serious adverse events. Thus, there may be a role for CDB-2914 in the treatment of leiomyomata.

Clinical Trial Registration: ClinicalTrials.gov,www.clinicaltrials.gov, NCT00290251

LEVEL OF EVIDENCE: I






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