PDF(Pubmed)
Abstract：
OBJECTIVE: To assess the efficacy of topical sildenafil cream, 3.6% among healthy premenopausal women with female sexual arousal disorder.
METHODS: We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale-Desire, Arousal, Orgasm).
RESULTS: Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84). Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P =.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P ≤.04).
CONCLUSIONS: Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress.
BACKGROUND: ClinicalTrials.gov , NCT04948151.
METHODS: We conducted a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream. Coprimary efficacy endpoints were the change from baseline to week 12 in the Arousal Sensation domain of the SFQ28 (Sexual Function Questionnaire) and question 14 of the FSDS-DAO (Female Sexual Distress Scale-Desire, Arousal, Orgasm).
RESULTS: Two hundred women with female sexual arousal disorder were randomized to sildenafil cream (n=101) or placebo cream (n=99). A total of 174 participants completed the study (sildenafil 90, placebo 84). Among the intention-to-treat (ITT) population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, although the sildenafil cream group demonstrated greater improvement in the SFQ28 Arousal Sensation domain scores, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. An exploratory post hoc subset of the ITT population with an enrollment diagnosis of female sexual arousal disorder with or without concomitant decreased desire randomized to sildenafil cream reported significant increases in their SFQ28 Arousal Sensation domain score (least squares mean 2.03 [SE 0.62]) compared with placebo cream (least squares mean 0.08 [SE 0.71], P =.04). This subset achieved a larger mean improvement in the SFQ28 Desire and Orgasm domain scores. This subset population also had significantly reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by FSDS-DAO questions 3, 5, and 10 (all P ≤.04).
CONCLUSIONS: Topical sildenafil cream improved outcomes among women with female sexual arousal disorder, most significantly in those who did not have concomitant orgasmic dysfunction. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil cream increased sexual arousal sensation, desire, and orgasm and reduced sexual distress.
BACKGROUND: ClinicalTrials.gov , NCT04948151.
摘要：
目的：评估西地那非乳膏外用的疗效，3.6%的健康绝经前女性女性性唤起障碍。
方法：我们进行了第2b阶段，探索性,随机化，安慰剂对照,西地那非乳膏的双盲研究.共同功效终点是SFQ28（性功能问卷）的唤醒感觉领域从基线到第12周的变化和FSDS-DAO（女性性困扰量表-欲望，唤醒，性高潮）。
结果：两百名女性性唤起障碍患者被随机分为西地那非乳膏（n=101）或安慰剂乳膏（n=99）。共有174名参与者完成了这项研究（西地那非90名，安慰剂84名）。在意向治疗(ITT)人群中，其中包括仅患有女性性唤起障碍的女性和患有女性性唤起障碍并伴有性功能障碍诊断或生殖器疼痛的女性，尽管西地那非乳膏组在SFQ28觉醒感觉领域评分方面表现出更大的改善，西地那非和安慰剂乳膏使用者在联合主要和次要疗效终点方面无统计学显著差异.ITT人群的一个探索性事后子集，诊断为女性性唤起障碍，有或没有伴随的欲望下降，随机分配到西地那非乳膏，报告其SFQ28觉醒感觉领域得分显着增加（最小二乘平均值2.03[SE0.62]）与安慰剂乳膏（最小二乘平均值0.08[SE0.71]，P=.04）。该子集在SFQ28欲望和性高潮领域得分中实现了更大的平均改善。根据FSDS-DAO问题3、5和10（所有P≤.04），使用西地那非乳膏时，该子集人群的性困扰和人际关系困难也显着减少。
结论：外用西地那非乳膏可改善女性性唤起障碍患者的预后，在没有并发性高潮功能障碍的患者中最显著。特别是,在对女性性唤起障碍患者的一部分进行的探索性分析中，有或没有伴随的欲望下降，局部用西地那非乳膏增加性唤起感，欲望,性高潮和减少性困扰。
背景：ClinicalTrials.gov，NCT04948151。
方法：我们进行了第2b阶段，探索性,随机化，安慰剂对照,西地那非乳膏的双盲研究.共同功效终点是SFQ28（性功能问卷）的唤醒感觉领域从基线到第12周的变化和FSDS-DAO（女性性困扰量表-欲望，唤醒，性高潮）。
结果：两百名女性性唤起障碍患者被随机分为西地那非乳膏（n=101）或安慰剂乳膏（n=99）。共有174名参与者完成了这项研究（西地那非90名，安慰剂84名）。在意向治疗(ITT)人群中，其中包括仅患有女性性唤起障碍的女性和患有女性性唤起障碍并伴有性功能障碍诊断或生殖器疼痛的女性，尽管西地那非乳膏组在SFQ28觉醒感觉领域评分方面表现出更大的改善，西地那非和安慰剂乳膏使用者在联合主要和次要疗效终点方面无统计学显著差异.ITT人群的一个探索性事后子集，诊断为女性性唤起障碍，有或没有伴随的欲望下降，随机分配到西地那非乳膏，报告其SFQ28觉醒感觉领域得分显着增加（最小二乘平均值2.03[SE0.62]）与安慰剂乳膏（最小二乘平均值0.08[SE0.71]，P=.04）。该子集在SFQ28欲望和性高潮领域得分中实现了更大的平均改善。根据FSDS-DAO问题3、5和10（所有P≤.04），使用西地那非乳膏时，该子集人群的性困扰和人际关系困难也显着减少。
结论：外用西地那非乳膏可改善女性性唤起障碍患者的预后，在没有并发性高潮功能障碍的患者中最显著。特别是,在对女性性唤起障碍患者的一部分进行的探索性分析中，有或没有伴随的欲望下降，局部用西地那非乳膏增加性唤起感，欲望,性高潮和减少性困扰。
背景：ClinicalTrials.gov，NCT04948151。
