Recent Updates
Recently added Catalysts

Nanomilled testosterone

Phase 2

Hypogonadism | Small molecule | Endocrine |GSK plc|Last Updated: May 30, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0039858028-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal MenPHASE2 COMPLETED 43Oct 1, 2006Oct 1, 2007May 30, 20177 United States
NCT00400335Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without DutasteridePHASE1 COMPLETED 60Oct 1, 2006 -Jun 4, 20121 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
days 1 and 28
lab tests for relative bioavailability of testosterone and dutasteride,
days 1, 2, 3, 19, 20, 21 & 26-31
Secondary Endpoints
Testosterone concentration .
on days 1 and 28
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
days 1 and 28.
Anabolic & androgenic Pharmacodynamic biomarkers
pre- and post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Nanomilled testosteroneDRUG -
Nanomilled dutasterideDRUG -
commercially available dutasterideDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexMALE
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Have a diagnosis of primary or secondary hypogonadism. * Have very low testosterone levels on 2 separate days. * Have a BMI within range of 18.5-35kg/m2. * Have not taken dutasteride for one year, or finasteride for the past 3 months. Exclusion criteria: * Have had or have b...

Countries:United States
Unlock Eligibility Criteria