a George Washington University School of Medicine , IntimMedicine Specialists , Washington , DC , USA.
b Department of Gynecology and Reproductive Sciences , University of California, Sutter East Bay Medical Foundation , Berkeley , CA , USA.
Climacteric. 2019 Aug;22(4):412-418. doi: 10.1080/13697137.2019.1577379. Epub 2019 Mar 12.
This study aimed to evaluate improvement of dyspareunia and associated vaginal dryness with a 17β-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal atrophy (VVA). Postmenopausal women with VVA and moderate to severe dyspareunia received TX-004HR (4, 10, or 25 μg) or placebo in the 12-week, randomized, double-blind, placebo-controlled, phase 3 REJOICE trial. analyses examined improvement levels in dyspareunia and concurrent vaginal dryness with TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Significantly more women treated with TX-004HR (all doses) than placebo had complete resolution or substantial improvement in dyspareunia or vaginal dryness (concurrent with dyspareunia) by 12 weeks, observed as early as week 2 with most doses. TX-004HR significantly improved both dyspareunia and vaginal dryness at least one level versus placebo by week 12 in women with both symptoms. Subgroup analyses showed TX-004HR improved vaginal dryness associated with dyspareunia regardless of age, body mass index, uterine status, prior pregnancy, and vaginal birth number. TX-004HR provided clinically meaningful improvements in dyspareunia and vaginal dryness associated with dyspareunia in postmenopausal women with VVA. Clinicians may be able to use this information when discussing patients' expectations regarding symptom improvement with the estradiol vaginal insert.
本研究旨在评估 17β-雌二醇软胶囊阴道给药（TX-004HR；TherapeuticsMD，佛罗里达州博卡拉顿）治疗绝经后外阴和阴道萎缩（VVA）患者性交困难和相关阴道干燥的改善情况。VVA 伴中重度性交困难的绝经后女性参与 TX-004HR（4、10 或 25μg）或安慰剂为期 12 周的随机、双盲、安慰剂对照、3 期 REJOICE 试验。分析评估了 TX-004HR 改善性交困难和同时出现的阴道干燥的程度，并评估了患者特征对阴道干燥治疗的影响。与安慰剂相比，接受 TX-004HR（所有剂量）治疗的女性在 12 周时性交困难完全缓解或显著改善的比例明显更高，大多数剂量在第 2 周即可观察到这种情况，阴道干燥也有同样的情况。TX-004HR 可显著改善同时伴有性交困难的女性的性交困难和阴道干燥，至少在 12 周时比安慰剂改善一个级别。亚组分析表明，TX-004HR 改善了与性交困难相关的阴道干燥，无论年龄、体重指数、子宫状况、既往妊娠和阴道分娩次数如何。TX-004HR 为 VVA 绝经后女性的性交困难和相关阴道干燥提供了具有临床意义的改善。临床医生在讨论患者对雌二醇阴道插入剂改善症状的期望时，可以使用这些信息。
