Session: SUN 176-202-Male Reproductive Endocrinology and Male Reproductive Tract (posters)
Bench to Bedside
Poster Board SUN 198
Methods: SOAR is a randomized, active–controlled, 2-arm, 12-months, open-label, multicenter, dose-titration trial that included 314 hypogonadal (T<300ng/dl on 2 separate days) men between the ages of 18 and 80 years old. Participants were randomized to either LPCN 1021 (n=210) or Androgel® 1.62% (n=104). Of the 314 randomized hypogonadal men, 164 (52%) of them had a comorbid condition of cardiovascular disorder (CVD+) at baseline. The LPCN 1021 dose could be titrated up (e.g. if T Cave, 24h <300 mg/dL) or down (e.g. if T Cmax was >1500 mg/dL) at weeks 4 and 8 based on 24 h PK, if required. Androgel 1.62% was titrated based on manufacturer’s instruction. Sexual function and mood changes were assessed by the Psychosexual Daily Questionnaire (PDQ) for 7 days preceding visits. In addition, quality of life (QoL) was assessed by the SF-36 questionnaire at weeks 1and 52 (end of study, EOS).
Results: Hypogonadal subjects with CVD+ (n=164; 52%) were significantly older (p<0.001), and had higher SHBG levels (p=0.002), and greater vitality (p=0.028); baseline T levels were comparable (p=NS). Men with CVD+ had worse erections (p=0.010) and more difficulty maintaining erections (p=0.001) compared to hypogonadal subjects without CVD at baseline. Treatment with LPCN 1021 resulted in greater reduction of LDL, cholesterol and triglycerides in hypogonadal subjects with CVD+ compared to those without CVD both at baseline (p=0.033, p=0.011 and p=0.091) and EOS (p=0.005, p<0.001 and p=0.014), respectively. Non-significant differences were observed for the same parameters with Androgel 1.62%. In addition, hypogonadal patients with CVD+ treated with LPCN 1021 had significant improvements at EOS compared to baseline for vitality (p=0.006), depressed mood (p<0.001), mental component summary (p=0.017), penile rigidity (p<0.001) and ability to maintain erections (p<0.001).
Conclusions: Twice daily administration of oral LPCN 1021 improves psychosexual symptoms in hypogonadal men with or without CVD.
Disclosure: MK: Consultant, Lipocine, Inc., Consultant, Abbott Laboratories, Consultant, Endo Pharmaceuticals. ASD: Principal Investigator, Endo Pharmaceuticals, Principal Investigator, Clarus, Principal Investigator, Abbott Laboratories, Consultant, Lipocine. CW: Principal Investigator, Clarus, Principal Investigator, Lipocine, Principal Investigator, Besins HealthCare, Principal Investigator, Prolor, Advisory Group Member, Lipocine, Advisory Group Member, TesoRX. JCK: Principal Investigator, Abbott Laboratories, Principal Investigator, Antares, Principal Investigator, Auxillium, Principal Investigator, Clarus, Principal Investigator, Ferring Pharmaceuticals, Principal Investigator, Lipocine. IG: Consultant, Strategic Sciences and Technologies, Consultant, TesoRx, Researcher, Shionogi, Speaker, Coloplast, Collaborator, Female Health Co.,, Speaker, Nuelle, Speaker, Sprout, Speaker, sprout, Principal Investigator, Endo Pharmaceuticals, Principal Investigator, Lipocine. MMM: Principal Investigator, Forest, Principal Investigator, NERI, Principal Investigator, Abbott Laboratories, Consultant, Lipocine, Consultant, Repros. AD: Consultant, Lipocine, Inc.. NC: Employee, Lipocine, Inc.. SN: Employee, Lipocine, Inc.. MP: Founder, Lipocine, Inc..
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