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Testosterone

Phase 1

Obesity | Small molecule | Metabolic |Abbott Laboratories|Last Updated: May 14, 2014

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
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01160328Influence of Male Hormones on Regional Fat MetabolismPHASE1 COMPLETED 39Jun 1, 2010Jan 1, 2013May 14, 20141 United States
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Study Endpoints
Primary Endpoints
Regional Fat Metabolism
3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Control GroupNO_INTERVENTIONParticipants in this group will not receive any treatment.
Lupron GroupEXPERIMENTALParticipants in this group will receive leuprolide acetate (Lupron) treatment for 7 weeks resulting in temporary decreases in testosterone levels.
Lupron & Testosterone GroupOTHERParticipants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).
Interventions
NameTypeDescription
LeuprolideDRUG7.5 mg - 1 month depot, 2 doses over 7 weeks
TestosteroneDRUG7.5g - 1% testosterone gel, daily x 7 weeks
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, weight stable individuals * BMI 20-29 kg/m2 Exclusion Criteria: * Smoking and tobacco use * Diabetes and other disease * Anti-depressants

Countries:United States
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