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testosterone undecanoate, LPCN 1021

Phase 3

Male Hypogonadism | Small molecule | Endocrine |Lipocine Inc.|Last Updated: Oct 23, 2017

Success Probability
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment315
FDA Designations
No designations recorded
Clinical trial landscape

testosterone undecanoate, LPCN 1021 · 1 trial · 1 indication

Phase 3 1
NCT02081300Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or HypogonadismMale Hypogonadism
COMPLETED315 Analytics
PHASE3COMPLETED
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Male Hypogonadism
NCT02081300315
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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 to 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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