Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial

Fang Ping Chen, Chee Jen Chang, An Shine Chao, Hong Yuan Huang, Jian Pei Huang, Meng Hsing Wu, Ching Chou Tsai, Fu Tsai Kung, Ching-Wen Chang, Yung Chieh Tsai

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4 Citations (Scopus)

Abstract

Objective: To assess the effects of 2 months of treatment with Femarelle for climacteric syndrome in Taiwanese postmenopausal women. Materials and methods: A multi-center, open-label trial of 260 postmenopausal women, age ≥ 45 years with vasomotor symptoms. Women were enrolled after obtaining a detailed medical history and a thorough physical examination. They then received Femarelle (640 mg/d) twice daily for 8 weeks. The primary outcome was the changes in the frequency and severity of hot flushes from baseline to 4 weeks (1 month) and 8 weeks (2 months). Changes of general climacteric syndrome were assessed using a modified climacteric scale designed by Greene. Results: The frequency and severity of hot flushes were significantly improved with Femarelle use (p < 0.001). After 8 weeks of treatment, the percentage of women with various climacteric syndromes was reduced (from 100% to 20.9% for hot flushes, from 97.7% to 87.9% for psychological symptoms, from 93.8% to 78.8% for somatic symptoms, and from 87.8% to 74.9% for sexual symptoms). General climacteric syndrome scores also significantly decreased, from 20.8 ± 0.7 at the time of enrollment to 12.9 ± 0.7 after 8 weeks of Femarelle treatment (p < 0.0001). Participants experienced improvement of various climacteric symptoms and signs after 8 weeks of treatment (75.1% for hot flushes, 68.7% for psychological symptoms, 70.6% for somatic symptoms, and 69.0% for sexual problems respectively). After 4 weeks and 8 weeks of treatment with Femarelle, patients showed statistically significant improvement in climacteric symptoms (p < 0.0001). Three women (1.2%) withdrew from the study after 4 weeks of treatment due to adverse effects. Conclusion: Femarelle significantly improved climacteric symptoms in Taiwanese postmenopausal women. However, further evaluation is needed regarding the safety of long-term consumption.

Original languageEnglish
Pages (from-to)336-340
Number of pages5
JournalTaiwanese Journal of Obstetrics and Gynecology
Volume55
Issue number3
DOIs
Publication statusPublished - Jun 1 2016

Keywords

  • Climacteric syndrome
  • Femarelle
  • Hot flushes
  • Postmenopausal women

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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  • Cite this

    Chen, F. P., Chang, C. J., Chao, A. S., Huang, H. Y., Huang, J. P., Wu, M. H., Tsai, C. C., Kung, F. T., Chang, C-W., & Tsai, Y. C. (2016). Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial. Taiwanese Journal of Obstetrics and Gynecology, 55(3), 336-340. https://doi.org/10.1016/j.tjog.2016.04.008