Gynecologic Cancer Center, CHA Ilsan Medical Center, CHA University College of Medicine, 1205 Jungang-ro, Ilsandong-gu, Goyang-si 10414, Republic of Korea.
Department of Obstetrics and Gynecology, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul 02841, Republic of Korea.
Medicina (Kaunas). 2023 Jul 28;59(8):1382. doi: 10.3390/medicina59081382.
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 ( = 0.789 and = 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 ( = 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.
本研究旨在通过分析库珀曼指数（主要终点）和激素变化（次要终点），评估 Unicenta 在有更年期症状的女性受试者中的疗效和安全性。这是一项在两个不同的三级医疗中心进行的随机、多中心、双盲、平行、非劣效性临床研究。基于库珀曼指数，Unicenta 注射在意向治疗和符合方案人群中均显示非劣效于 Melsmon（=0.789 和=0.826）。此外，激素水平（雌二醇、卵泡刺激素）或潮红评估方面无统计学显著差异。两组不良事件发生率无统计学显著差异（=0.505）。研究表明，Unicenta 在注射后 12 天库珀曼指数的变化方面不劣于 Melsmon。Unicenta 的疗效和安全性得到了证实，改善了更年期症状。
