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

Research output: Contribution to journalArticle

2 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

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Therapeutics
Psychology
DT56a
Signs and Symptoms
Physical Examination
Safety
Medically Unexplained Symptoms

Keywords

  • Climacteric syndrome
  • Femarelle
  • Hot flushes
  • Postmenopausal women

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women : An open label trial. / Chen, Fang Ping; Chang, Chee Jen; Chao, An Shine; Huang, Hong Yuan; Huang, Jian Pei; Wu, Meng Hsing; Tsai, Ching Chou; Kung, Fu Tsai; Chang, Ching-Wen; Tsai, Yung Chieh.

In: Taiwanese Journal of Obstetrics and Gynecology, Vol. 55, No. 3, 01.06.2016, p. 336-340.

Research output: Contribution to journalArticle

Chen, Fang Ping ; Chang, Chee Jen ; Chao, An Shine ; Huang, Hong Yuan ; Huang, Jian Pei ; Wu, Meng Hsing ; Tsai, Ching Chou ; Kung, Fu Tsai ; Chang, Ching-Wen ; Tsai, Yung Chieh. / Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women : An open label trial. In: Taiwanese Journal of Obstetrics and Gynecology. 2016 ; Vol. 55, No. 3. pp. 336-340.
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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.",
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AU - Chang, Chee Jen

AU - Chao, An Shine

AU - Huang, Hong Yuan

AU - Huang, Jian Pei

AU - Wu, Meng Hsing

AU - Tsai, Ching Chou

AU - Kung, Fu Tsai

AU - Chang, Ching-Wen

AU - Tsai, Yung Chieh

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N2 - 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.

AB - 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.

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KW - Femarelle

KW - Hot flushes

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