Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00861484 | Proof of Mechanism in ELT | PHASE1 | COMPLETED | 33 | — | — | Nov 26, 2008 | Dec 11, 2009 | Jun 14, 2017 | 1 | Italy |
| NCT00664365 | FTIH Study With GSK958108 | PHASE1 | COMPLETED | 21 | — | — | Apr 12, 2008 | Aug 22, 2008 | Aug 1, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| GSK958108 3 mg | EXPERIMENTAL | Experimental |
| Placebo of GSK958108 | PLACEBO_COMPARATOR | Placebo |
| Subjects receiving GSK958108 + placebo in cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK958108 with a starting dose of 1 milligram. The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period. |
| Subjects receiving GSK958108 + placebo in cohort 2 | EXPERIMENTAL | Eligible subjects will start dosing once the cohort 1 has completed the treatment phase and the initial dose will be the same as top dose in Cohort1.The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period. |
| Name | Type | Description |
|---|---|---|
| GSK958108 | DRUG | Coated Tablets 1 mg |
| Placebo | DRUG | Coated tablets |
Inclusion Criteria: * 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 co...