Open Access, Peer-reviewed
pISSN 2288-6478
eISSN 2288-6761
    J Korean Soc Menopause. 2013 Apr;19(1):36-44. Korean.
    Published online Apr 26, 2013.
    https://doi.org/10.6118/jksm.2013.19.1.36
    Copyright © 2013 by The Korean Society of Menopause
    Original Article

    Comparison of the Efficacy and Safety of the Unicenta and Melsmon Injection for the Menopausal Symptoms

    Seongmin Kim, M.D.,1 Hyun Tae Park, M.D.,1 Byung Ik Lee, M.D.,2 Jung Ho Shin, M.D.,1 Hyung Moo Park, M.D.,3 and Tak Kim, M.D.1
      • 1Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, Korea.
      • 2Department of Obstetrics and Gynecology, Inha University College of Medicine, Incheon, Korea.
      • 3Department of Obstetrics and Gynecology, Chung-Ang University College of Medicine, Seoul, Korea.
    • Address for Correspondence: Tak Kim, Department of Obstetrics and Gynecology, Korea University Anam Hospital, Korea University College of Medicine, 126-1, 5-ga, Anam-dong, Seongbuk-gu, Seoul 136-705, Korea. Tel: +82-2-920-6842, Fax: +82-2-921-5357, Email: tkim@kumc.or.kr
    Received February 08, 2013; Revised February 20, 2013; Accepted March 19, 2013.

    This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/).

    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.

    Keywords
    Kupperman index; Menopause; Placental extract

    Figures

    Fig. 1
    Visit number and follow-up duration of the participants.

    Fig. 2
    Trial profile. ITT: intent-to-treat, PP: per-protocol.

    Tables

    Table 1
    The number of participants and population in each group

    Table 2
    Baseline characteristics of the participants in the intent-to-treat population

    Table 3
    Comparison of the change in the Kupperman index from baseline to visit 8 according to the intent-to-treat, per-protocol population

    Table 4
    Comparison of the secondary efficacy endpoint in the intent-to-treat population

    Table 5
    Comparison of the secondary efficacy endpoint in the per-protocol population

    References

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    MeSH Terms
    Female
    Humans
    Menopause
    Vital Signs
    Metrics
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