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Testosterone

Phase 1

Aging | Small molecule | Other |GSK plc|Last Updated: Jul 31, 2012

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 Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00309855Testosterone-Driven Growth-Hormone (GH) Secretion in Aging MenPHASE1 COMPLETED 80Dec 1, 2005Aug 1, 2008Jul 31, 20121 United States
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Study Endpoints
Primary Endpoints
Growth Hormone concentration after injections
24 days

GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1).

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Double PlaceboPLACEBO_COMPARATOR(i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days)
Testosterone IM and oral placeboOTHERIM injections weekly x three injections and oral placebo once daily x 21 days
Testosterone and Oral AnastrozoleOTHERIM injections weekly x 3 injections and oral daily x 21 days
Testosterone and DutasterideOTHERIM injections weekly x 3 injections and oral once daily x 21 days
Interventions
NameTypeDescription
PlaceboDRUGim and orally
TestosteroneDRUGinjections
AnastrazoleDRUGorally x 21 days
DutasterideDRUGorally x 21 days
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Eligibility Criteria
Age Range50 Years — 80 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy men between the ages of 50 and 80; * normal weight (within 30% of ideal body weight defined by New York Metropolitan Life tables); and * normal hematocrit (greater than 38%); * community dwelling; and * voluntarily consenting Exclusion Criteria: * recent use of psych...

Countries:United States
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