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AndroGel 1.62% is 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.
Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions.
Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy.(See Dosage and Administration.)
The safety and efficacy of testosterone replacement therapy in men with low testosterone concentrations related to aging have not been established.(See Late-onset Hypogonadism under Uses: Uses in Males.)
Uses in Males
Hypogonadism
In males, testosterone is used for the management of congenital or acquired primary hypogonadism such as that resulting from orchiectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, or vanishing testis syndrome. Testosterone also is used in males for the management of congenital or acquired hypogonadotropic hypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin-releasing hormone (luteinizing hormone releasing hormone) deficiency or from pituitary-hypothalamic injury caused by tumors, trauma, or radiation. If any of these conditions occur before puberty, androgen replacement therapy will be necessary during adolescence for the development of secondary sexual characteristics and prolonged therapy will be required to maintain these characteristics. Prolonged androgen therapy also is required to maintain sexual characteristics in other males who develop testosterone deficiency after puberty.
Manifestations
Hypogonadism in males may manifest with signs and symptoms of testosterone deficiency and/or infertility, with manifestations depending principally on the age of the patient at the time of development. Hypogonadism seldom is recognized before the age of puberty unless it is associated with growth retardation or other anatomic and/or endocrine abnormalities. When hypogonadism develops before puberty onset, manifestations include small testes, phallus, and prostate; minimal pubic and axillary hair; disproportionately long arms and legs (secondary to delayed epiphyseal closure); reduced male musculature; gynecomastia; and a persistently high-pitched voice. Postpubertal loss of testicular function results in slowly evolving subtle clinical manifestations, which may be difficult to appreciate in aging men because they often are attributed to growing old. Growth of body hair usually slows, while the voice and size of the phallus and prostate remain unchanged. Patients with postpubertal hypogonadism may manifest a progressive decrease in muscle mass, libido loss, impotence, oligospermia or azoospermia, and/or occasionally menopause-type hot flushes (with acute onset of hypogonadism). Hypogonadism also is associated with a risk of osteoporosis and resultant fractures. Many cases of postpubertal hypogonadism are initially detected during fertility evaluations.