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J Korean Soc Menopause. 2013 Apr;19(1):36-44. Korean. Multicenter Study. https://doi.org/10.6118/jksm.2013.19.1.36
Kim S , Park HT , Lee BI , Shin JH , Park HM , Kim T .
Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, Korea. tkim@kumc.or.kr
Department of Obstetrics and Gynecology, Inha University College of Medicine, Incheon, Korea.
Department of Obstetrics and Gynecology, Chung-Ang University College of Medicine, Seoul, Korea.
Abstract

OBJECTIVES: The objective of this study was to evaluate the efficacy of Unicenta (UNCNT) and Melsmon in women with the menopausal symptoms, by analysing the changes in the Kupperman index (primary endpoint), and the hormonal change (secondary endpoint). METHODS: This is a randomized, multi-Center, double-Blind, parallel, non-inferiority clinical study of four different tertiary medical centers. We began the participant recruitment in September 2011, with 218 patients applied over 7 months. All participants had the last visit in April 2012. RESULTS: The Unicenta injection was not inferior to that of Melsmon as measured by the Kupperman index following the injection in both the intent-to-treat and the per-protocol populations (P = 0.63, P = 0.85, respectively). Side effects occurred in 14.0% of the cases (15 patients/18 cases) in the case group, and in 12.6% (14 patients/15 cases) in the control group (P value=0.7599). None were reported to be associated with the medication. The laboratory results and the vital signs showed no statistically significant risk for safety. CONCLUSION: The study showed that Unicenta is not inferior to Melsmon in the change of the Kupperman index after 12 days of injection. The efficacy and safety of Unicenta was shown, with the improvement of the menopausal symptoms.

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