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Obstetrics & Gynecology 2004;103:245-253
© 2004 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Relief of Hot Flushes With New Plant-Derived 10-Component Synthetic Conjugated Estrogens

Wulf H. Utian, MD, PhD, Samuel A. Lederman, MD, Brenda M. Williams, MD, Rhonda Y. Vega, DVM, William D. Koltun, MD and Thomas W. Leonard, PhD

From The Cleveland Clinic, Rapid Medical Research, Cleveland, Ohio; Radiant Research, West Palm Beach, Florida; Boise, Idaho; Endeavor Pharmaceuticals, Inc, Wilmington, North Carolina; and Medical Center for Clinical Research, San Diego, California.

Address reprint requests to: Wulf H. Utian, MD, 5900 Landerbrook Drive, Suite 195, Mayfield Heights, OH 44124; e-mail: Utian{at}menopause.org.

OBJECTIVE: A study was conducted to evaluate the safety and efficacy of 3 different doses of synthetic conjugated estrogens B, a new plant-derived 10-component conjugated estrogens product, for the treatment of menopausal vasomotor symptoms.

METHODS: This was a randomized, double-blind, placebo-controlled trial. Highly symptomatic menopausal women (N = 281) received 12 weeks of a once-daily oral treatment with 0.3 mg, 0.625 mg, or 1.25 mg of 10-component synthetic conjugated estrogen or placebo. Patients recorded the daily frequency and severity of hot flushes. Statistical analyses compared results at weeks 4, 8, and 12 with baseline values.

RESULTS: Statistically significant reductions (P < .05) in the frequency and severity of vasomotor symptoms were observed for all 3 dosage strengths of 10-component synthetic conjugated estrogen compared with placebo. The most commonly reported adverse events in all treatment groups were headaches. No difference in the incidence of treatment-related adverse events was seen between placebo and 10-component synthetic conjugated estrogen groups.

CONCLUSION: The 0.3-mg, 0.625-mg and 1.25-mg dose strengths of 10-component synthetic conjugated estrogen significantly reduced the frequency and severity of vasomotor symptoms compared with placebo, and were well tolerated during this 12-week study.

LEVEL OF EVIDENCE: I




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