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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK958108 3 mg | Experimental | Experimental |
|
| Placebo of GSK958108 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK958108 | Drug | Coated Tablets 1 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli | 50 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Verona | Veneto | 37134 | Italy |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study 111155 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111155 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Drug |
Coated tablets |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111155 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |