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Taiwan J Obstet Gynecol · Jun 2016
Multicenter Study Clinical TrialEfficacy 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, and Yung-Chieh Tsai.
- Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan. Electronic address: fangping@cgmh.org.tw.
- Taiwan J Obstet Gynecol. 2016 Jun 1; 55 (3): 336-40.
ObjectiveTo assess the effects of 2 months of treatment with Femarelle for climacteric syndrome in Taiwanese postmenopausal women.Materials And MethodsA 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.ResultsThe 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.ConclusionFemarelle significantly improved climacteric symptoms in Taiwanese postmenopausal women. However, further evaluation is needed regarding the safety of long-term consumption.Copyright © 2016. Published by Elsevier B.V.
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