Session: OR34-Testosterone Replacement Therapy: Risks and Benefits
Room 6A (San Diego Convention Center)
Methods: SOAR is a randomized, active-controlled, 2-arm, 12-month, open-label, multicenter, dose-titration trial that included 18- to 80-year-old hypogonadal (T <300 ng/dL on 2 separate days) men. Participants were randomized to either oral LPCN 1021 (n=210) or Androgel® 1.62% (n=105). The starting dose was 225 mg LPCN 1021 BID taken with a meal. The dose could be titrated up (eg, if T Cave,24h <300 mg/dL) or down (eg, if T Cmax was >1500 mg/dL) at weeks 4 and 8 based on 24 h PK. Efficacy was assessed on week 13 based on T Cave,24h from serum samples collected over 24 h for T assayed by LC-MS/MS. Analysis was conducted using the Efficacy Population Set (subjects with ≥1 PK profile and no significant protocol deviations; N=152 LPCN 1021).
Results: LPCN 1021 reliably restored and maintained T levels in the eugonadal range (300-1140 ng/dL) in 88% of hypogonadal men (lower bound 95% CI=81.9%). Mean T Cave,24h value was 447±166 ng/dL, consistent with other non-oral TRT therapies. There was no significant dose timing effect (eg, AM vs PM), suggesting consistent intra-day performance. Overall variability was low (37% CV for Cave,24h). 82.9% of subjects had serum T peak (Cmax) <1500 ng/dL, <5% had Cmax 1800-2500 ng/dL, and only 2% had serum T levels >2500 ng/dL, and those cases were sporadic, transient, and isolated, with no associated clinical events. 85% of subjects required ≤1 dose adjustment, suggesting a safe and effective titration algorithm.
Conclusions: LPCN 1021 is an orally administered TRT product with acceptable Cave and Cmax excursions, consistent with US FDA targets met by other non-oral TRT products. LPCN 1021 may improve patient adherence as a generally safe, effective, and more convenient option compared to topical, transdermal, injectable, or implanted TRT products.
Disclosure: CW: Clinical Researcher, Clarus, Consultant, Clarus, Clinical Researcher, Lipocine, Inc., Clinical Researcher, Antares, Clinical Researcher, Prolor, Consultant, Lipocine, Advisory Group Member, TesoRx. AD: Consultant, Lipocine, Inc.. JCK: Principal Investigator, AbbVie, Principal Investigator, Lipocine, Inc., Principal Investigator, Ferring Pharmaceuticals, Principal Investigator, Clarus, Principal Investigator, Antares, Consultant, Antares, Principal Investigator, Auxillium, Consultant, Auxillium, Speaker, Auxillium. MMM: Clinical Researcher, NERI, Clinical Researcher, Forest, Consultant, AbbVie, Consultant, Lipocine, Inc., Consultant, Repros. SV: Employee, Lipocine, Inc.. NC: Employee, Lipocine, Inc.. SN: Employee, Lipocine, Inc.. MP: Employee, Lipocine, Inc.. ASD: Consultant, AbbVie, Advisory Group Member, AbbVie, Advisory Group Member, Endo Pharmaceuticals, Advisory Group Member, Lipocine, Inc., Clinical Researcher, Endo Pharmaceuticals, Clinical Researcher, Clarus. Nothing to Disclose: PRY
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