NCT00479570已完成2 期
Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.
研究概览
简要总结
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have evidence of Female Sexual Arousal Disorder.
- •Women who experience personal distress due to Female Sexual Dysfunction.
- •Post menopausal women aged between 45 and 65 years.
排除标准
- •Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
- •Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
- •Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
研究组 & 干预措施
Study period 1, 2 or 3
Experimental
干预措施: PF-00446687 (Drug)
Placebo Study period 1, 2 or 3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.
时间窗: From day of dosing until 7 days post-dose
次要结局
- Assess effect of single doses on medium term (1 week) sexual arousal and interest.(Until 7 days post-dose)
- Assess variability of response and repeatability of design between 2 similar doses.(Comparison of response to be assessed until 7 days post dose)
- If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.(Day of dosing)
- Assess PK , safety and toleration on day 1 of each study period.(Day of dosing)
研究者
研究点 (1)
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