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Kim, Park, Lee, Shin, Park, and Kim: Comparison of the Efficacy and Safety of the Unicenta and Melsmon Injection for the Menopausal Symptoms
Original Article
The Journal of Korean Society of Menopause

The Journal of Korean Society of Menopause 2013; 19(1): 36-44.

Published online: 26 April 2013

DOI: https://doi.org/10.6118/jksm.2013.19.1.36

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, 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, tkim@kumc.or.kr

Received 8 February 2013       Revised 20 February 2013       Accepted 19 March 2013

Copyright © 2013 by The Korean Society of Menopause

(open-access):

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 and Tables

Fig. 1
Visit number and follow-up duration of the participants.
jksm-19-36-g001
Fig. 2
Trial profile. ITT: intent-to-treat, PP: per-protocol.
jksm-19-36-g002
Table 1
The number of participants and population in each group
jksm-19-36-i001
Table 2
Baseline characteristics of the participants in the intent-to-treat population
jksm-19-36-i002

*P value is obtained by Student's t-test, †P value is obtained by Chi-square test.

N: number, SD: standard deviation, Min: minimum, Max: maximum

Table 3
Comparison of the change in the Kupperman index from baseline to visit 8 according to the intent-to-treat, per-protocol population
jksm-19-36-i003

*Students' t-test, †Paired t-test [Baseline - visit8] gap between two groups = ([Baseline - visit 8] in Treatment group) - ([Baseline - visit 8] in Control group).

ITT: intent-to-treat, PP: per-protocol

Table 4
Comparison of the secondary efficacy endpoint in the intent-to-treat population
jksm-19-36-i004

*P values are obtained by Student's t-test; Values are expressed as mean ± standard deviation.

Change = (data at Visit 1 - data at Visit 8).

E2: estradiol, FSH: follicle stimulating hormone

Table 5
Comparison of the secondary efficacy endpoint in the per-protocol population
jksm-19-36-i005

*P values are obtained by Student's t-test; Values are expressed as mean ± standard deviation.

Change = (data at Visit 1 - data at Visit 8).

E2: estradiol, FSH: follicle stimulating hormone

References

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