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1 Indications And Usage Testosterone Topical Solution Usp Is Indicated For Replacement Therapy In Males For Conditions Associated With A Deficiency Or Absence Of Endogenous Testosterone: Primary Hypogonadism (Congenital Or Acquired) ( 1 ) Hypogonadotropic Hypogonadism (Congenital Or Acquired) ( 1 ) Limitations Of Use: Safety And Efficacy Of Testosterone Topical Solution Usp In Men With "age-Related Hypogonadism" Have Not Been Established. ( 1 ) Safety And Efficacy Of Testosterone Topical Solution Usp In Males <18 Years Old Have Not Been Established ( 8.4 ) Testosterone Topical Solution Usp Is Indicated For Replacement Therapy In Males For Conditions Associated With A Deficiency Or Absence Of Endogenous Testosterone: Primary Hypogonadism (Congenital Or Acquired): Testicular Failure Due To Conditions Such As Cryptorchidism, Bilateral Torsion, Orchitis, Vanishing Testis Syndrome, Orchiectomy, Klinefelter's Syndrome, Chemotherapy, Or Toxic Damage From Alcohol Or Heavy Metals. These Men Usually Have Low Serum Testosterone Concentrations And Gonadotropins (Fsh, Lh) Above The Normal Range. Hypogonadotropic Hypogonadism (Congenital Or Acquired): Gonadotropin Or Luteinizing Hormone-Releasing Hormone (Lhrh) Deficiency Or Pituitary-Hypothalamic Injury From Tumors, Trauma, Or Radiation. These Men Have Low Testosterone Serum Concentrations But Have Gonadotropins In The Normal Or Low Range. Limitations Of Use: Safety And Efficacy Of Testosterone Topical Solution Usp In Men With "age-Related Hypogonadism" (Also Referred To As "late-Onset Hypogonadism") Have Not Been Established. Safety And Efficacy Of Testosterone Topical Solution Usp In Males <18 Years Old Have Not Been Established [See Use In Specific Populations ( 8.4 )] .
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