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136 Testosterone Replacement Therapy in Adolescents with Sickle Cell Disease Reverses Hypogonadism without Promoting Priapism
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Proceedings of the 21st Annual Fall Scientific Meeting of SMSNA, Las Vegas, Nevada, USA, November 19-22, 2015
of men with increased cardiovascular risk was observed for 6 of 7 cardiovascular markers (Table 1). Conclusions: Our findings support prior published studies demonstrating increased CV risk in hypogonadal men. Disclosure: Work supported by industry: yes, by Singulex, Inc. (industry funding only - investigator initiated and executed study).
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Objectives: Few studies have evaluated the effects of growth hormone releasing peptides (GHRPs), such as sermorelin (serm), GHRP-2 and GHRP-6, on growth hormone (GH) and insulinlike growth factor-1 (IGF-1) levels in humans. Here we present data to evaluate the impact of low dose GHRPs on IGF-1 levels as a surrogate marker for GH in men. Material and Methods: Retrospective chart review was performed for 122 men prescribed either sermorelin 0.5 or 1 mg daily, sermorelin + GHRP-2 (serm/GHRP2) 0.1 or 0.2 mg 1-3 times daily, or sermorelin + GHRP-2 + GHRP-6 (serm/ GHRP2/6) 0.1 or 0.2 mg 1-3 times daily. Serum IGF-1 levels, body weight, and body fat percentage were assessed as a function of GHRP prescribed; dose, duration of treatment and concomitant T therapy status were also analysed. Results: Mean (SD) age within the cohort was 42.6 (21-68) years, and baseline serum IGF-1 level was 163.7 (50-308) ng/mL. Median (range) duration of continuous treatment was 499 (27-879) days. Within the cohort, 11 men were on GHRP therapy alone and the remaining 111 were on concomitant T therapy. Across the entire cohort, serum IGF-1 levels (p¼0.21), body weight (p¼0.44), and body fat percentage (p¼0.89) did not significantly change during follow-up. However, subgroup analysis of men with pretreatment IGF-1 levels < 150 ng/mL yielded a trend towards a significant increase during GHRP therapy (p¼0.08). When evaluating men on and off T therapy, no significantly changes in IGF-1 levels were observed. When men were grouped by serm, serm/GHRP2, and serm/GHRP2/6 and subdivided by dose, no significant changes in serum IGF-1 levels were observed. Conclusions: Low-dose GHRP therapy does not increase IGF-1 levels using standard hormonal testing or changes in body weight or fat. To reach a significant clinical end point, men on GHRP therapy may require markedly increased dose adjustment or direct GH evaluation to better quantitate hormonal changes. Disclosure: Work supported by industry: no.
TESTOSTERONE REPLACEMENT THERAPY IN ADOLESCENTS WITH SICKLE CELL DISEASE REVERSES HYPOGONADISM WITHOUT PROMOTING PRIAPISM Morrison, B.1,*; Madden, W.1; Gabay, L.1 1 University of the West Indies, Jamaica Objective: Delayed puberty secondary to hypogonadism is commonly seen in sickle cell disease (SCD), affecting the normal growth and development as well as psychosocial status of affected adolescents. The condition is uncommonly treated in SCD for fear of inducing priapism episodes which is also commonly seen in this disorder. A causal association between testosterone replacement therapy (TRT) and priapism in SCD has never been proven, however affected adolescents suffer increased morbidity due to non-treatment. To our knowledge, this is the first report documenting the safety of TRT in adolescents with hypogonadism and SCD. Materials and Methods: We present 2 case reports of AfroJamaican adolescent males at 16 years of age who presented to the Sickle Cell Unit, University of the West Indies, Kingston, Jamaica with symptoms and signs of delayed puberty. Endocrinological assessment revealed low serum total testosterone levels in both males (50 ng/dl; < 20 ng/dl). Serum follicle stimulating hormone, luteinizing hormone and cortisol levels were normal in both. Bone age corresponded to 10 and 11.5 years respectively. One patient reported recurrent ischemic priapism episodes occurring nightly. Both adolescents were treated monthly with 50 mg testosterone enanthate with increasing doses for 12 months. Both patients were monitored serially for changes in total testosterone levels and anthropometric measures. Results: TRT resulted in increased serum total testosterone in both patients (210 ng/dl at 11 months; 141 ng/dl at 12 months). There was complete resolution of recurrent ischemic priapism episodes after 3 months of TRT in the single patient with a prior history of frequent episodes. No episodes of priapism were induced in the other patient. Both patients had improvement in anthropometric measures and early resolution of delayed puberty. Conclusion: TRT improved symptoms of delayed puberty in adolescent males with SCD and hypogonadism. The treatment did not appear to promote priapism episodes. Future controlled studies investigating the role of androgens in hypogonadism in SCD are warranted. Disclosure: Work supported by industry: no.
LOW DOSE GROWTH HORMONE RELEASING PEPTIDE TREATMENT DOES NOT INCREASE SERUM IGF-1 LEVELS IN MEN Lindgren, M.C.1,*; Ohlander, S.J.1; Sigalos, J.T.1; Pastuszak, A.W.1; Herati, A.S.1; Lipshultz, L.I.1 1 Baylor College of Medicine, USA
138 EFFECT OF TESTOSTERONE SOLUTION ON TOTAL TESTOSTERONE, SEX DRIVE AND ENERGY IN HYPOGONADAL MEN Heiselman, D.1,*; Dowsett, S.1 1 USA Objective(s): We assessed the effect of testosterone solution 2% (Axiron®) on serum total testosterone (TT) concentration and on 2 common symptoms in hypogonadal men, decreased sex drive and energy level. J Sex Med 2016;13:S1eS71
Proceedings of the 21st Annual Fall Scientific Meeting of SMSNA, Las Vegas, Nevada, USA, November 19-22, 2015
of men with increased cardiovascular risk was observed for 6 of 7 cardiovascular markers (Table 1). Conclusions: Our findings support prior published studies demonstrating increased CV risk in hypogonadal men. Disclosure: Work supported by industry: yes, by Singulex, Inc. (industry funding only - investigator initiated and executed study).
137
136
Objectives: Few studies have evaluated the effects of growth hormone releasing peptides (GHRPs), such as sermorelin (serm), GHRP-2 and GHRP-6, on growth hormone (GH) and insulinlike growth factor-1 (IGF-1) levels in humans. Here we present data to evaluate the impact of low dose GHRPs on IGF-1 levels as a surrogate marker for GH in men. Material and Methods: Retrospective chart review was performed for 122 men prescribed either sermorelin 0.5 or 1 mg daily, sermorelin + GHRP-2 (serm/GHRP2) 0.1 or 0.2 mg 1-3 times daily, or sermorelin + GHRP-2 + GHRP-6 (serm/ GHRP2/6) 0.1 or 0.2 mg 1-3 times daily. Serum IGF-1 levels, body weight, and body fat percentage were assessed as a function of GHRP prescribed; dose, duration of treatment and concomitant T therapy status were also analysed. Results: Mean (SD) age within the cohort was 42.6 (21-68) years, and baseline serum IGF-1 level was 163.7 (50-308) ng/mL. Median (range) duration of continuous treatment was 499 (27-879) days. Within the cohort, 11 men were on GHRP therapy alone and the remaining 111 were on concomitant T therapy. Across the entire cohort, serum IGF-1 levels (p¼0.21), body weight (p¼0.44), and body fat percentage (p¼0.89) did not significantly change during follow-up. However, subgroup analysis of men with pretreatment IGF-1 levels < 150 ng/mL yielded a trend towards a significant increase during GHRP therapy (p¼0.08). When evaluating men on and off T therapy, no significantly changes in IGF-1 levels were observed. When men were grouped by serm, serm/GHRP2, and serm/GHRP2/6 and subdivided by dose, no significant changes in serum IGF-1 levels were observed. Conclusions: Low-dose GHRP therapy does not increase IGF-1 levels using standard hormonal testing or changes in body weight or fat. To reach a significant clinical end point, men on GHRP therapy may require markedly increased dose adjustment or direct GH evaluation to better quantitate hormonal changes. Disclosure: Work supported by industry: no.
TESTOSTERONE REPLACEMENT THERAPY IN ADOLESCENTS WITH SICKLE CELL DISEASE REVERSES HYPOGONADISM WITHOUT PROMOTING PRIAPISM Morrison, B.1,*; Madden, W.1; Gabay, L.1 1 University of the West Indies, Jamaica Objective: Delayed puberty secondary to hypogonadism is commonly seen in sickle cell disease (SCD), affecting the normal growth and development as well as psychosocial status of affected adolescents. The condition is uncommonly treated in SCD for fear of inducing priapism episodes which is also commonly seen in this disorder. A causal association between testosterone replacement therapy (TRT) and priapism in SCD has never been proven, however affected adolescents suffer increased morbidity due to non-treatment. To our knowledge, this is the first report documenting the safety of TRT in adolescents with hypogonadism and SCD. Materials and Methods: We present 2 case reports of AfroJamaican adolescent males at 16 years of age who presented to the Sickle Cell Unit, University of the West Indies, Kingston, Jamaica with symptoms and signs of delayed puberty. Endocrinological assessment revealed low serum total testosterone levels in both males (50 ng/dl; < 20 ng/dl). Serum follicle stimulating hormone, luteinizing hormone and cortisol levels were normal in both. Bone age corresponded to 10 and 11.5 years respectively. One patient reported recurrent ischemic priapism episodes occurring nightly. Both adolescents were treated monthly with 50 mg testosterone enanthate with increasing doses for 12 months. Both patients were monitored serially for changes in total testosterone levels and anthropometric measures. Results: TRT resulted in increased serum total testosterone in both patients (210 ng/dl at 11 months; 141 ng/dl at 12 months). There was complete resolution of recurrent ischemic priapism episodes after 3 months of TRT in the single patient with a prior history of frequent episodes. No episodes of priapism were induced in the other patient. Both patients had improvement in anthropometric measures and early resolution of delayed puberty. Conclusion: TRT improved symptoms of delayed puberty in adolescent males with SCD and hypogonadism. The treatment did not appear to promote priapism episodes. Future controlled studies investigating the role of androgens in hypogonadism in SCD are warranted. Disclosure: Work supported by industry: no.
LOW DOSE GROWTH HORMONE RELEASING PEPTIDE TREATMENT DOES NOT INCREASE SERUM IGF-1 LEVELS IN MEN Lindgren, M.C.1,*; Ohlander, S.J.1; Sigalos, J.T.1; Pastuszak, A.W.1; Herati, A.S.1; Lipshultz, L.I.1 1 Baylor College of Medicine, USA
138 EFFECT OF TESTOSTERONE SOLUTION ON TOTAL TESTOSTERONE, SEX DRIVE AND ENERGY IN HYPOGONADAL MEN Heiselman, D.1,*; Dowsett, S.1 1 USA Objective(s): We assessed the effect of testosterone solution 2% (Axiron®) on serum total testosterone (TT) concentration and on 2 common symptoms in hypogonadal men, decreased sex drive and energy level. J Sex Med 2016;13:S1eS71