[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel design, phase III study of the efficacy and safety of pratestosterone vaginal suppository (INTRAROSA®) in the treatment of postmenopausal vulvovaginal atrophy (VVA).
主要研究目的:在中国人群中,评价普拉睾酮阴道栓对绝经后外阴阴道萎缩(VVA)疗效,通过以下四个方面较基线的改变:中-重度性交疼痛(性交困难)且作为最困扰症状的严重程度变化(VASQ)、阴道pH值、阴道表层细胞和旁基底细胞所占百分比的变化。
[Translation] MAIN STUDY OBJECTIVE: To evaluate the efficacy of pratestosterone vaginal suppository for postmenopausal vulvovaginal atrophy (VVA) in a Chinese population, as measured by changes from baseline in four areas: moderate-severe dyspareunia (dyspareunia) as the most distressing symptom Changes in severity of changes (VASQ), vaginal pH, and changes in the percentage of vaginal surface cells and parabasal cells.