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testosterone

Phase 1

Skin Androgenization | Small molecule | Dermatology |Merck & Company, Inc.|Last Updated: Sep 4, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00969163A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).PHASE1 COMPLETED 30Oct 1, 2004Jun 1, 2005Sep 4, 2014 -
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Study Endpoints
Primary Endpoints
serum free testosterone concentrations following multiple doses of AndroGel
6 weeks
Secondary Endpoints
mean percent change from baseline in sebum excretion
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL2.5 mg testosterone gel
2EXPERIMENTAL300 ug testosterone gel
3PLACEBO_COMPARATORplacebo gel
Interventions
NameTypeDescription
testosterone gelDRUG300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
Comparator: placeboDRUGtransdermal placebo gel for 6 weeks
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Eligibility Criteria
Age Range50 Years — 65 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is at least 3 years postmenopausal * Subject is in good general health * Subject is willing to avoid excess alcohol or strenuous physical activity during the study Exclusion Criteria: * Subject has donated a unit of blood or has taken an investigational drug in anoth...

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