Cargando…

A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement

This study was conducted to evaluate the efficacy and safety of Unicenta in female subjects with menopausal symptoms by analyzing the changes in the Kupperman index (primary endpoint) and hormonal changes (secondary endpoint). It was a randomized, multi-center, double-blind, parallel, non-inferiorit...

Descripción completa

Detalles Bibliográficos
Autores principales: Kim, Seongmin, Lee, Sanghoon, Ahn, Ki-Hoon, Park, Hyun-Tae, Song, Jae-Yun, Hong, Soon-Cheol, Kim, Tak
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10456340/
https://www.ncbi.nlm.nih.gov/pubmed/37629679
http://dx.doi.org/10.3390/medicina59081382
_version_ 1785096673694842880
author Kim, Seongmin
Lee, Sanghoon
Ahn, Ki-Hoon
Park, Hyun-Tae
Song, Jae-Yun
Hong, Soon-Cheol
Kim, Tak
author_facet Kim, Seongmin
Lee, Sanghoon
Ahn, Ki-Hoon
Park, Hyun-Tae
Song, Jae-Yun
Hong, Soon-Cheol
Kim, Tak
author_sort Kim, Seongmin
collection PubMed
description This study was conducted to evaluate the efficacy and safety of Unicenta in female subjects with menopausal symptoms by analyzing the changes in the Kupperman index (primary endpoint) and hormonal changes (secondary endpoint). It was a randomized, multi-center, double-blind, parallel, non-inferiority clinical study conducted at two different tertiary medical centers. A Unicenta injection was shown to be non-inferior to Melsmon based on the Kupperman index in both the intent-to-treat and per-protocol populations (p = 0.789 and p = 0.826, respectively). Additionally, there were no statistically significant differences in hormone levels (estradiol, follicular-stimulating hormone) or in the evaluation of facial flushes. There was no statistically significant difference in the incidence rate of adverse events between the two groups (p = 0.505). The study demonstrated that Unicenta is not inferior to Melsmon in terms of the change in the Kupperman index after 12 days of injection. The efficacy and safety of Unicenta were shown, resulting in the improvement of menopausal symptoms.
format Online
Article
Text
id pubmed-10456340
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-104563402023-08-26 A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement Kim, Seongmin Lee, Sanghoon Ahn, Ki-Hoon Park, Hyun-Tae Song, Jae-Yun Hong, Soon-Cheol Kim, Tak Medicina (Kaunas) Article This study was conducted to evaluate the efficacy and safety of Unicenta in female subjects with menopausal symptoms by analyzing the changes in the Kupperman index (primary endpoint) and hormonal changes (secondary endpoint). It was a randomized, multi-center, double-blind, parallel, non-inferiority clinical study conducted at two different tertiary medical centers. A Unicenta injection was shown to be non-inferior to Melsmon based on the Kupperman index in both the intent-to-treat and per-protocol populations (p = 0.789 and p = 0.826, respectively). Additionally, there were no statistically significant differences in hormone levels (estradiol, follicular-stimulating hormone) or in the evaluation of facial flushes. There was no statistically significant difference in the incidence rate of adverse events between the two groups (p = 0.505). The study demonstrated that Unicenta is not inferior to Melsmon in terms of the change in the Kupperman index after 12 days of injection. The efficacy and safety of Unicenta were shown, resulting in the improvement of menopausal symptoms. MDPI 2023-07-28 /pmc/articles/PMC10456340/ /pubmed/37629679 http://dx.doi.org/10.3390/medicina59081382 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kim, Seongmin
Lee, Sanghoon
Ahn, Ki-Hoon
Park, Hyun-Tae
Song, Jae-Yun
Hong, Soon-Cheol
Kim, Tak
A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title_full A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title_fullStr A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title_full_unstemmed A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title_short A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement
title_sort randomized, multicenter, double-blind, parallel, non-inferiority clinical study to compare the efficacy and safety of unicenta and melsmon for menopausal symptom improvement
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10456340/
https://www.ncbi.nlm.nih.gov/pubmed/37629679
http://dx.doi.org/10.3390/medicina59081382
work_keys_str_mv AT kimseongmin arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT leesanghoon arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT ahnkihoon arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT parkhyuntae arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT songjaeyun arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT hongsooncheol arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT kimtak arandomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT kimseongmin randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT leesanghoon randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT ahnkihoon randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT parkhyuntae randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT songjaeyun randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT hongsooncheol randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement
AT kimtak randomizedmulticenterdoubleblindparallelnoninferiorityclinicalstudytocomparetheefficacyandsafetyofunicentaandmelsmonformenopausalsymptomimprovement