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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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 - 2016 Jun 1

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynaecology

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    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