E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036596 |
E.1.2 | Term | Premature ejaculation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of a single oral dose of GSK958108 To investigate the pharmacokinetics of GSK958108 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:00 Data:2008/10/15 Titolo:Studio in doppio cieco, a gruppi paralleli, controllato con placebo per valutare leffetto di una dose orale singola di GSK958108 sul tempo di latenza eiaculatoria (ELT) in pazienti maschi affetti da eiaculazione precoce. Obiettivi:-valutare una possibile relazione genetica nella risposta a GSK958108.
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E.3 | Principal inclusion criteria |
-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. |
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E.4 | Principal exclusion criteria |
-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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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |