Stute P, May T W, Masur C, Schmidts-Winkler I M
Department of Obstetrics and Gynecology , University of Bern , Switzerland.
Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.
To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan(®) Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief.
This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom score.
Regarding VVA symptom relief, results confirmed non-inferiority of CREAM compared to GEL and even indicated superiority of CREAM. Frequency and intensity of subjective symptoms and objective findings were clearly reduced, with CREAM showing better results compared to GEL. Mean VVA objective symptom score significantly decreased; improvement was significantly greater with CREAM. Vaginal pH decreased only following CREAM treatment. Tolerability was superior for CREAM: burning and itching, mostly rated as mild, occurred markedly less often with CREAM than with GEL. Overall satisfaction with treatment efficacy, tolerability and most product properties were rated significantly superior for CREAM.
Subjective and objective VVA symptoms were reliably and safely reduced by both non-hormonal topical products. However, efficacy and tolerability of CREAM were shown to be superior to GEL.
证明德国首款非激素阴道乳膏Vagisan®保湿乳膏（CREAM）与一种用于缓解外阴阴道萎缩（VVA）症状的非激素阴道凝胶（GEL）相比具有非劣效性。
这是一项为期12周的多中心、开放标签、前瞻性、随机、两阶段、交叉III期试验。主要终点是各治疗期的VVA主观症状累积评分。次要终点包括对单个VVA主观和客观症状的评估、VVA客观症状评分、阴道pH值、安全性参数、疗效总体评估、耐受性以及产品特性评估。共有117名女性被随机分配至两种治疗方法中的一种，每种治疗持续4周；92名女性纳入符合方案分析（主要分析）。主要结局指标是VVA主观症状累积评分。
关于VVA症状缓解，结果证实CREAM与GEL相比具有非劣效性，甚至表明CREAM具有优越性。主观症状和客观发现的频率及强度均明显降低，与GEL相比，CREAM效果更佳。VVA客观症状平均评分显著降低；CREAM的改善更为显著。仅在使用CREAM治疗后阴道pH值下降。CREAM的耐受性更佳：烧灼感和瘙痒大多被评为轻度，CREAM出现的频率明显低于GEL。对治疗效果、耐受性和大多数产品特性的总体满意度，CREAM的评分显著更高。
两种非激素局部用产品均能可靠且安全地减轻VVA的主观和客观症状。然而，CREAM的疗效和耐受性优于GEL。
