IR@PKUHSC  > 北京大学第一临床医学院
学科主题临床医学
Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population
Liao, Qinping1; Zhang, Miao1; Geng, Li2; Wang, Xiangping3; Song, Xuehong4; Xia, Pei3; Lu, Tao1; Lu, Mingqi1; Liu, Vivian5
关键词alprostadil topical female arousal disorder trial
刊名JOURNAL OF SEXUAL MEDICINE
2008-08-01
DOI10.1111/j.1743-6109.2008.00876.x
5期:8页:1923-1931
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Urology & Nephrology
研究领域[WOS]Urology & Nephrology
关键词[WOS]FUNCTION INDEX FSFI ; ERECTILE DYSFUNCTION ; TOPICAL ALPROSTADIL ; SILDENAFIL CITRATE ; WOMEN ; VALIDATION ; PROSTAGLANDIN-E1 ; PHENTOLAMINE ; DEFINITIONS ; PREVALENCE
英文摘要

Introduction. To date, no approved medication is available for the treatment of female sexual arousal disorder (FSAD).

Aim. The purpose of this study was to evaluate the clinical efficacy and safety of a novel alprostadil topical cream for the treatment of FSAD.

Methods. This was a multicenter, randomized, double blind, placebo-controlled, parallel design dose-ranging study. Four hundred female patients with FSAD (22-62 years of age), after a 4-week nontreatment baseline period, were provided with 10 blinded doses of 500, 700, or 900 mcg alprostadil or a placebo cream to be applied to the clitoris and the G-spot in the vagina prior to vaginal intercourse.

Main Outcome Measures. The primary efficacy end point was the arousal success rate (equal number of the Yes responses to Question 3 of the Female Sexual Encounter Profile [FSEP] or number of the sexual encounters). Secondary endpoints included the Female Sexual Function Index (FSFI), Global Assessment Questionnaire, other FSEP question responses, and post-treatment changes in Female Sexual Distress Scale.

Results. A total of 374 FSAD patients completed the study. Primary efficacy analysis of the intent-to-treat (ITT) population showed a significant increase in arousal success rates with dose. Arousal success rates at the end of the total evaluation period were 33.1%, 46.3% (P = 0.0161), 43.5% (P = 0.0400), and 53.9% (P = 0.0002) in the placebo, 500, 700, and 900 mcg alprostadil groups, respectively. The changes of the FSFI score, relative to baseline were 14.7%, 20.7% (P = 0.067), 21.7% (P = 0.035), and 22.9% (P = 0.002) for the placebo, 500, 700, and 900 mcg treatment groups, respectively. The other secondary efficacy end point values showed a consistent trend in support of the primary efficacy results.

Conclusion. These results demonstrated that the application of topical alprostadil prior to vaginal intercourse significantly improved the sexual arousal rate of the subjects with FSAD.

语种英语
WOS记录号WOS:000258074000016
引用统计
被引频次:20[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/61666
专题北京大学第一临床医学院
北京大学第三临床医学院_妇产科
作者单位1.Peking Univ, Hosp 1, Dept Obstet & Gynecol, Beijing 100871, Peoples R China
2.Peking Univ, Hosp 3, Dept Obstet & Gynecol, Beijing, Peoples R China
3.Capital Med Univ, Xuanwu Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China
4.Capital Med Univ, Beijing Chaoyang Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China
5.NexMed USA Inc, E Windsor, NJ USA
推荐引用方式
GB/T 7714
Liao, Qinping,Zhang, Miao,Geng, Li,et al. Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population[J]. JOURNAL OF SEXUAL MEDICINE,2008,5(8):1923-1931.
APA Liao, Qinping.,Zhang, Miao.,Geng, Li.,Wang, Xiangping.,Song, Xuehong.,...&Liu, Vivian.(2008).Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population.JOURNAL OF SEXUAL MEDICINE,5(8),1923-1931.
MLA Liao, Qinping,et al."Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population".JOURNAL OF SEXUAL MEDICINE 5.8(2008):1923-1931.
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