Diagnosing Patients

Diagnostic evaluation

1

Check

Review history, ask questions, and perform a physical to establish a general understanding of the patient’s current health state and assess the underlying etiology.1,3

2

Test

Perform a morning total testosterone level test.1,3

  • If this blood test shows a normal testosterone level, no further action is required, and it’s recommended you follow up as needed3
3

Confirm

Confirm hypogonadism with a second morning total testosterone level test and an LH+FSH test.1,3

  • Use FT or bioavailable testosterone if altered SHBG is suspected3
  • If testosterone levels are normal upon repeat blood test measurement, no further action is required, and it’s recommended you follow up as needed3
  • Confirm hypogonadism is due to an associated medical condition1,3
4

Exclude

If testosterone levels are low, exclude reversible illness, drugs, and nutritional deficiency.3

  • Under certain circumstances while considering differential diagnosis, may need to measure prolactin, iron, other pituitary hormones and conduct MRI3
5

Diagnose

Primary hypogonadism: Defined as low testosterone resulting from testicular defect. Low testosterone level, high LH+FSH3

Secondary hypogonadism: Defined as low testosterone resulting from pituitary or hypothalamic defect. Low testosterone level, low or normal LH+FSH3

A man sitting at a table

Behind every bottle of AndroGel 1.62% there are clear reasons to treat each man: the medical conditions that lead to hypogonadism, the responsibility of medicine to provide care, and the ultimate goal of getting men back into the normal range.1

Hypogonadism and its associated conditions

AndroGel 1.62% treatment is approved for patients with primary or secondary adult male hypogonadism due to an associated medical condition.1

Primary hypogonadism1,3

  • Defined as low testosterone resulting from testicular defect
  • Characterized by low testosterone and elevated LH and FSH levels

Associated medical conditions
of primary hypogonadism1

  • Klinefelter’s syndrome
  • Bilateral torsion
  • Chemotherapy
  • Orchitis
  • Cryptorchidism
  • Vanishing testis syndrome
  • Toxic damage from alcohol or
    heavy metals
  • Orchiectomy

This is not an exhaustive list of conditions.

Secondary hypogonadism1,3

  • Defined as low testosterone resulting from pituitary or hypothalamic defect
  • Characterized by low testosterone and LH and FSH levels that are low or normal

Associated medical conditions of secondary hypogonadism1

  • Gonadotropin or luteinizing
    hormone-releasing hormone
    (LHRH) deficiency
  • Pituitary-hypothalamic injury
    • Tumors
    • Trauma
    • Radiation

This is not an exhaustive list of conditions.

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.

LH=luteinizing hormone; FSH=follicle-stimulating hormone; FT=free testosterone; SHBG=sex hormone-binding globulin.

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