TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women.
In: Climacteric, Jg. 22 (2019-08-01), Heft 4, S. 412-418
academicJournal
Zugriff:
Objective: 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). Methods: 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. Post hoc analyses examined improvement levels in dyspareunia and concurrent vaginal dryness with TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Results: 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. Conclusion: 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. [ABSTRACT FROM AUTHOR]
目的:本研究旨在评估患有绝经后外阴和阴道萎缩 (VVA) 的妇女应用17β-雌二醇软胶囊阴道插入物 (TX-004HR, TherapeuticsMD, Boca Raton, FL, USA) 对性交困难以及相关的阴道干燥的改善状况。 方法:在为期12周的随机, 双盲, 安慰剂对照的3期REJOICE试验中, 患有VVA和中度至重度性交困难的绝经后妇女接受TX-004HR (4, 10或25μg) 或安慰剂。事后分析检查了TX-004HR对性交困难和与之并存的阴道干燥的改善程度, 并评估了患者特征对阴道干燥治疗的影响。 结果:接受TX-004HR (所有剂量) 治疗的妇女中在12周时出现性交困难或阴道干燥 (与性交困难并发) 的症状完全缓解或明显改善的数量明显多于安慰剂组, 而服用最多剂量的妇女最早在第2周就出现了这种情况。与安慰剂组相比, 对于同时患有性交困难和阴道干燥的女性, TX-004HR在第12周时至少在一个水平上可以明显改善这两种症状。亚组分析显示TX-004HR改善了与性交困难相关的阴道干燥, 而与年龄, 体重指数, 子宫状态, 既往妊娠和阴道分娩数量无关。 结论:TX-004HR为患有VVA的绝经后妇女的性交困难和与性交困难相关的阴道干燥提供了临床上有意义的改善。在讨论患者对雌二醇阴道插入物改善症状的期望时, 临床医生可能能够使用这些信息。 [ABSTRACT FROM AUTHOR]
Titel: |
TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women.
|
---|---|
Autor/in / Beteiligte Person: | Simon, J. A. ; Kagan, R. ; Archer, D. F. ; Constantine, G. D. ; Bernick, B. ; Graham, S. ; Mirkin, S. |
Zeitschrift: | Climacteric, Jg. 22 (2019-08-01), Heft 4, S. 412-418 |
Veröffentlichung: | 2019 |
Medientyp: | academicJournal |
ISSN: | 1369-7137 (print) |
DOI: | 10.1080/13697137.2019.1577379 |
Schlagwort: |
|
Sonstiges: |
|