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testosterone undecanoate, LPCN 1021

Phase 3

Male Hypogonadism | Small molecule | Endocrine |Lipocine Inc.|Last Updated: Oct 23, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment315
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02081300Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or HypogonadismPHASE3 COMPLETED 315 — — Feb 1, 2014May 1, 2015Oct 23, 2017 - —
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Study Endpoints
Primary Endpoints
Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.
Following 13 weeks of treatment
Secondary Endpoints
Percentage of LPCN 1021-treated subjects with maximum serum T concentrations (Cmax) values that are (a) less than 1500 ng/dL; (b) between 1800 and 2500 ng/dL, and (c) greater than 2500 ng/dL
Following 13 weeks of treatment
Change from baseline in patient reported outcomes for LPCN 1021 (i.e., International Prostate Symptom Score [I-PSS], Psychosexual Daily Questionnaire [PDQ], Short Form-36 Questionnaire [SF-36])
52 weeks
Change from baseline to 52 weeks in safety laboratory parameters (i.e., clinical chemistry, hematology, PSA)
52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Oral testosterone undecanoate, LPCN 1021EXPERIMENTALOral testosterone undecanoate: Initial dose: 225 mg TU BID. Dose titrated up to 300 mg TU BID or down to 150 mg TU BID based on serum T at Week 3 and 7.
Topical testosterone gel 1.62 %OTHERTopical testosterone gel 1.62%: Initial dose: 40.5 mg T once daily. Dose titrated down to 20.25 mg or up to 81 mg based on serum T on Days 14 and 28
Interventions
NameTypeDescription
Oral testosterone undecanoate, LPCN 1021DRUG -
Topical testosterone gel 1.62 %DRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: 1. Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. Serum total testosterone \< 300 ng/dL based on 2 consecutive blood samples Exclusion Criteria: A subject will not be eligible for study partic...

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