``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 patients suffering from premature ejaculation.`` - ND

GLAXO SMITHKLINE0 个研究点开始时间: 2008年11月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-Male between 18 and 50 years of age -Body weight ≥ 50 kg (110 lbs) and BMI within the range 19.0 ? 29.9 kg/m2 inclusive) -Heterosexual orientation -Long term symptoms of PE that meet DSM-IV-TR criteria for PE -Premature ejaculation is not due to any other concomitant medical condition -Self-reported moderate or severe primary PE prior to screening -The patient has a baseline ELT less than 3 minutes -The subject has a visual acuity that is equivalent to 20/30 in each eye with appropriate correction if needed.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Erectile Dysfunction subjects should have Erectile Function domain of International Index of Erectile Function questionnaire >26 or normal -The subject has a history of migraine -The subject has a history of Psychiatric illness, except for those symptoms related to their PE -Any history of suicidal attempts or behaviour -The subject has a history of any eye disorder or is colour blind, excluding myopia and presbyopia -History of long QT syndrome (personal or family) or other clinically significant cardiac disease -Subject smokes more than 10 cigarettes per day -Regular use of any PDE-5 inhibitors

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