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

Obstet Gynecol. 2004 Feb;103(2):245-53. doi: 10.1097/01.AOG.0000109428.87940.31.

Abstract

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

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Estradiol Congeners / therapeutic use*
  • Estrogen Replacement Therapy / methods
  • Estrogens, Conjugated (USP) / administration & dosage*
  • Female
  • Hot Flashes / diagnosis
  • Hot Flashes / drug therapy*
  • Hot Flashes / etiology
  • Humans
  • Menopause / drug effects
  • Menopause / physiology
  • Middle Aged
  • Plant Extracts / administration & dosage*
  • Probability
  • Prognosis
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Estradiol Congeners
  • Estrogens, Conjugated (USP)
  • Plant Extracts