NCT00746967已完成2 期
An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2003年1月最近更新:
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
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Safety/toleration of oral sildenafil.
研究概览
简要总结
The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Included were subjects who completed Pfizer study A1481082 or A1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study.
- •For subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout.
- •Subjects should continue to maintain a stable sexual relationship throughout the study.
排除标准
- •Excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits.
- •Also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).
研究组 & 干预措施
Arm 1
Other
干预措施: sildenafil (Drug)
结局指标
主要结局
Safety/toleration of oral sildenafil.
时间窗: Continuous
次要结局
- The score for each of the individual questions 3,5 and 9 on the SQoL-F(Week 14 and Week 26)
- The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS)(Week 14 and Week 26)
- The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS(Week 14 and Week 26)
- The Arousal-lubrication Domain from the SFQ. The score for this domain is the sum of scores from Questions 11 and 12 from the SFQ(Week 14 and Week 26)
- The Arousal-sensation Domain from the SFQ. The score for this domain is sum of scores from Questions 7,8,9 and 10 from the SFQ.(Week 14 and Week 26)
- The total Quality of Life score on the Sexual Quality of Life (SQoL-F)(Week 14 and Week 26)
- The Desire domain from the SFQ. Specifically, the sum of scores from questions 1,2,3,4,15 and 28 (frequency of pleasurable thoughts, wanted to be touched, wanted sex, initiated sex, had sex with penetration, looked forward to sex, respectively).(Week 14 and Week 26)
- Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse).(Week 14 and Week 26)
- The Orgasm domain from the SFQ. The score for this domain is the sum of scores from questions 24,25 and 26 (orgasm frequency, level of pleasure and ease in achieving, respectively).(Week 14 and Week 26)
- The individual questions of the Orgasm domain.(Week 14 and Week 26)
- SFQ Question 27 (confidence as sexual partner).(Week 14 and Week 26)
- SFQ Question 29 (disappointment with response).(Week 14 and Week 26)
- Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life)(Week 14 and Week 26)
研究者
研究点 (1)
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