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GSK557296

Phase 2

Premature Ejaculation | Small molecule | Other |GSK plc|Last Updated: Sep 12, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01021553A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature EjaculationPHASE2 COMPLETED 77Dec 23, 2009May 5, 2011Sep 12, 20178 United States, Netherlands
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Study Endpoints
Primary Endpoints
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation
Up to Week 8

Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).

Secondary Endpoints
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation
Up to Week 8
Mean IELT Compared After the First Dose of Study Drug or Placebo
Up to Week 8
Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation
Baseline and up to Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
placeboPLACEBO_COMPARATORplacebo
50 mgACTIVE_COMPARATOR50 mg GSK557296
150 mgACTIVE_COMPARATOR150 mg GSK557296
Interventions
NameTypeDescription
GSK557296DRUG50 mg GSK557296
placeboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or...

Countries:United StatesNetherlands
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