1. Introduction
fatigue
SECONDARY, CHRONIC LIVER DISEASE
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 (Historically, the placenta has been used for health and beauty purposes through the ages [The placenta contains numerous nutrients and functional components as it serves as a substitute for all the necessary functions for the normal development of the fetus [In January 2006, the Korean Ministry of Food and Drug Safety announced the clinical re-evaluation for the safety and efficacy of pharmaceutical products derived from the placenta. Subsequently, after the completion of the re-evaluation, currently in South Korea, there are pharmaceutical products available for sale that include injectables for menopausal symptoms, injectables for improving liver function in chronic liver disease, and oral liquids for fatigue recovery and strengthening the body. In the clinical re-evaluation, the safety and efficacy of the placenta extract injection, Melsmon, were established. Unicenta is also used for the purpose of improving menopausal symptoms, with placental extract as its main ingredient.In this study, we aimed to evaluate the efficacy and safety of Unicenta in female subjects with menopausal symptoms. By demonstrating the non-inferiority of Unicenta compared to Melsmon, we sought to assess the effectiveness and safety of Unicenta.