Relief of hot flushes with new plant-derived 10-component synthetic conjugated estrogens.

Author(s): Utian WH, Lederman SA, Williams BM, Vega RY, Koltun WD, Leonard TW

Affiliation(s): Rapid Medical Research, The Cleveland Clinic, Cleveland, Ohio, USA. Utian@menopause.org

Publication date & source: 2004-02, Obstet Gynecol., 103(2):245-53.

Publication type: Clinical Trial; Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

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