Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for Women in women with and without female sexual arousal disorder
Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for Women in women with and without female sexual arousal disorder
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DOI：
10.1080/713847125
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发表时间：
2003-01-01
影响因子：
2.5
通讯作者：
Crosby, MG
中科院分区：
文献类型：
--
作者：
Ferguson, DM;Steidle, CP;Crosby, MG
Zestra for Women(TM) 是一种植物女性按摩油，涂抹在外阴时可增强女性性快感和性唤起。我们进行了这项随机、双盲、交叉研究，旨在评估 10 名患有女性性唤起障碍 (FSAD) 的女性和 10 名未患有女性性唤起障碍 (FSAD) 的女性在家庭使用与性活动相关的情况下与安慰剂油相比 Zestra for Women 的功效和安全性。通过体检、性治疗师访谈和问卷调查对受试者进行筛选。我们将合格的受试者随机分配到治疗路径，并给他们 5 剂测试物品和日记以供在家使用。在第 2 次访问时，我们通过问卷对他们进行了评估，并给了他们 5 剂交叉测试物品和日记供他们在家使用。在最后一次访问时，我们通过问卷对他们进行了评估。我们通过不良事件报告评估安全性，通过回答有关唤醒满意度的日记问题来评估主要疗效。次要功效工具包括剩余的日记问题、基于回忆的问卷、整体评估问题和消费者测试问卷。所有 20 名受试者均完成了研究。三名受试者报告在使用 Zestra for Women 后出现持续 5-30 分钟的轻度生殖器烧灼感。与安慰剂相比，正常女性和 FSAD 女性在性唤起水平、欲望水平、性唤起满意度、生殖器感觉、性高潮能力和性快感方面均显示出统计上显着的改善。尽管 FSAD 女性表现出更大程度的反应，但 FSAD 的存在对反应率没有影响。 Zestra for Women 对于使用选择性血清素再摄取抑制剂抗抑郁药的女性与不使用抗抑郁药的女性同样有效。 Zestra for Women 可改善正常和 FSAD 女性在家庭使用条件下的性功能。
Zestra for Women(TM) is a botanical feminine massage oil formulated to enhance female sexual pleasure and arousal when applied to the vulva. We conducted this randomized, double-blinded, crossover study to evaluate the efficacy and safety of Zestra for Women compared to placebo oil in 10 women with and 10 women without female sexual arousal disorder (FSAD) in conditions of home use in conjunction with sexual activities. Subjects were screened by physical examination, sex therapist interviews, and questionnaires. We randomized qualified subjects to treatment paths and gave them 5 doses of test article and diaries to use at home. At Visit 2, we assessed them by questionnaires and gave them 5 doses of crossover test article and diaries to use at home. At the final visit, we assessed them with questionnaires. We assessed safety by adverse event reports and primary efficacy by responses to a diary question regarding satisfaction with arousal. Secondary efficacy instruments included remaining diary questions, recall-based questionnaires, global assessment questions, and a consumer-testing questionnaire.All 20 subjects completed the study. Three subjects reported single incidences of mild genital burning sensations lasting 5-30 min after use of Zestra for Women. Both normal and FSAD women showed statistically significant improvements, relative to placebo, in level of arousal, level of desire, satisfaction with arousal, genital sensation, ability to have orgasms, and sexual pleasure. Although FSAD women showed greater magnitude of response, the presence of FSAD had no effect on response rates. Zestra for Women was just as effective in women using selective serotonin reuptake inhibitor antidepressants as in women not using antidepressants. Zestra for Women improved sexual function in normal and FSAD women under conditions of home use.