Chantrapanichkul Panicha, Tanmahasamut Prasong, Nanthiphatthanachai Arphamart, Wongwananuruk Thanyarat, Indhavivadhana Suchada, Rattanachaiyanont Manee, Sa-Nga-Areekul Nutchaya
Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Department of Obstetrics and Gynecology, Buddhachinaraj Hospital, Phitsanulok, Thailand.
Int J Gynaecol Obstet. 2025 Jul 22. doi: 10.1002/ijgo.70403.
To compare the effectiveness of two dosages (12.5 and 25 μg) of 17β-estradiol vaginal gel for treating postmenopausal vaginal atrophy.
A randomized non-inferiority trial was conducted in the Gynecologic Endocrinology and Menopause Clinic of a university hospital from June 2022 to February 2023. A total of 80 postmenopausal women were randomly assigned to receive a 12.5 μg (half-dose) or 25 μg (full-dose) 17β-estradiol vaginal gel daily for 14 days, followed by twice-weekly for 10 weeks. Efficacy outcomes were vaginal maturation value (VMV), vaginal health index (VHI), vaginal pH, most bothersome symptoms (MBSs), and female sexual function index (FSFI). Safety outcomes were endometrial thickness, serum estradiol level, and adverse events. All study outcomes were evaluated at three time points: baseline, week 4, and week 12.
At week 12, both the half-dose and full-dose groups displayed a significant improvement in the VMV, with median (25th-75th percentile) of 67.3 (59.1-72.9) and 71.8 (60.3-79.5), respectively. While the full-dose group exhibited slightly greater improvement in VMV, the difference was not statistically significant. The upper bound of the 95% confidence interval (CI) for the median difference in VMV was below the predefined non-inferiority margin of 15 (4.5, 95% CI: -0.5, 10.0; P = 0.082). Additionally, both groups demonstrated significant improvements from baseline in all efficacy outcomes without any safety concerns.
Both 12.5 and 25 μg doses of 17β-estradiol vaginal gel are safe and effectively improve vaginal atrophy in postmenopausal women. The non-inferiority of the half-dose to the full-dose suggests its potential as a cost-effective treatment option with comparable benefits.
比较两种剂量（12.5和25μg）的17β-雌二醇阴道凝胶治疗绝经后阴道萎缩的有效性。
2022年6月至2023年2月在一所大学医院的妇科内分泌与绝经门诊进行了一项随机非劣效性试验。共80名绝经后女性被随机分配，每天接受12.5μg（半剂量）或25μg（全剂量）的17β-雌二醇阴道凝胶，持续14天，随后每周两次，持续10周。疗效指标包括阴道成熟值（VMV）、阴道健康指数（VHI）、阴道pH值、最困扰症状（MBS）和女性性功能指数（FSFI）。安全性指标包括子宫内膜厚度、血清雌二醇水平和不良事件。所有研究指标在三个时间点进行评估：基线、第4周和第12周。
在第12周时，半剂量组和全剂量组的VMV均有显著改善，中位数（第25-75百分位数）分别为67.3（59.1-72.9）和71.8（60.3-79.5）。虽然全剂量组在VMV方面的改善略大，但差异无统计学意义。VMV中位数差异的95%置信区间（CI）上限低于预先定义的非劣效界值15（4.5，95%CI：-0.5，10.0；P=0.082）。此外，两组在所有疗效指标上均较基线有显著改善，且无任何安全问题。
12.5μg和25μg剂量的17β-雌二醇阴道凝胶均安全有效，可改善绝经后女性的阴道萎缩。半剂量与全剂量的非劣效性表明其作为一种具有可比益处的性价比高的治疗选择的潜力。
