AndroGel® (testosterone gel) 1% and 1.62% CIII are indicated for replacement therapy in adult 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 (follicle-stimulating hormone [FSH], luteinizing hormone [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 AndroGel 1% and 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism” ) have not been established.
- Safety and efficacy of AndroGel in males less than 18 years old have not been established.
- Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.