Abstract | OBJECTIVE: 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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Authors | Eric D Levens, Clariss Potlog-Nahari, Alicia Y Armstrong, Robert Wesley, Ahalya Premkumar, Diana L Blithe, Wendy Blocker, Lynnette K Nieman |
Journal | Obstetrics and gynecology
(Obstet Gynecol)
Vol. 111
Issue 5
Pg. 1129-36
(May 2008)
ISSN: 0029-7844 [Print] United States |
PMID | 18448745
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Norpregnadienes
- ulipristal
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Topics |
- Adult
- Female
- Health Status Indicators
- Hematocrit
- Humans
- Leiomyoma
(drug therapy)
- Magnetic Resonance Imaging
- Middle Aged
- Norpregnadienes
(administration & dosage, therapeutic use)
- Quality of Life
- Treatment Outcome
- Uterine Neoplasms
(drug therapy)
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