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学科主题: 临床医学
题名:
Efficacy and safety of alprostadil cream for the treatment of female sexual arousal disorder: A double-blind, placebo-controlled study in Chinese population
作者: 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
发表日期: 2008-08-01
DOI: 10.1111/j.1743-6109.2008.00876.x
卷: 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
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61666
Appears in Collections:北京大学第一临床医学院_期刊论文

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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

Recommended Citation:
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.
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