NCT00861484已完成1 期
A Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of a Single Oral Dose of GSK958108 on Ejaculatory Latency Time (ELT) in Male Patient Suffering From Premature Ejaculation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli
研究概览
简要总结
The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
- •Baseline Ejaculation Latency time < 3 minutes
- •Subjects must agree to use a contraception methods as per protocol
- •Body weight > or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2
- •Subject with normal visual acuity (with appropriate correction if needed)
- •Subject able to cooperate in all study procedure including the eye examination with use of mydriatics
排除标准
- •Erectile dysfunction
- •History of migraine
- •Current clinically relevant abnormality
- •History of psychiatric illness or suicidal attempts or behaviours
- •History of any eye disorder or colour blind, excluding myopia and presbyopia
- •Cardiac conduction disorder or other clinically significant cardiac disease
- •Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests
- •Regular consumption of alcohol
- •History of sensitivity or intolerance to drugs
- •Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids] from 7 days prior to the first dose of study medication
- •Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication
- •Participation in another clinical trial in the previous month
- •Exposure to more than four new experimental drugs within the previous 12 months
- •Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
研究组 & 干预措施
Placebo of GSK958108
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
GSK958108 3 mg
Experimental
Experimental
干预措施: GSK958108 (Drug)
结局指标
主要结局
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli
时间窗: 50 minutes
次要结局
- Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination(8 weeks)
- Blood concentration of GSK958108 at different timepoints(From predose to 30 hours post-dose)
研究者
研究点 (1)
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