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Restore testosterone levels with AndroGel 1.62%

Pivotal study

  • Primary endpoint: 82% of patients who were treated with AndroGel 1.62% achieved an average serum testosterone level within the normal range on Day 112 vs. 37% of hypogonadal men who were treated with placebo (p<0.0001).1
    • The average serum testosterone level for patients receiving all doses of AndroGel 1.62% on Day 112 was 561 ng/dL (±259 ng/dL).1

  • a40.5 mg daily dose.
  • b20.25 mg, 40.5 mg, 60.75 mg, and 81 mg daily doses.
  • Observed analaysis
    Prior to Day 56, some patients were still being titrated with AndroGel 1.62%.

Study Design
Multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men... Multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men with an average serum testosterone concentration <300 ng/dL as determined by two morning samples collected on the same day. Patients were initially randomized to receive 40.5 mg of AndroGel 1.62% or placebo. Patients returned to the clinic on days 14, 28, and 42 for predose serum total testosterone assessments, and their daily dose was titrated up or down in 20.25-mg increments if their level was outside the range of 350–750 ng/dL. Patients could have received one of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily) or placebo during the 182-day treatment period. The primary endpoint was the percentage of patients with an average serum testosterone level within the normal range (300–1000 ng/dL) on Day 112. Patients could agree to continue in an open-label, active-treatment maintenance period for an additional 182 days.2

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Safety Considerations2

Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use. AndroGel is contraindicated in men with breast cancer, known or suspected prostate cancer, and in women who are or may become pregnant, or are breastfeeding. Avoid unintentional exposure of women or children to AndroGel. Patients treated with AndroGel also may be at risk for development of worsening benign prostatic hyperplasia, prostate cancer, polycythemia, azoospermia, edema, gynecomastia, changes in lipid profile, and sleep apnea.

AndroGel 1.62% maintained testosterone levels for one year

Open-label extension (OLE) study

  • Testosterone levels were maintained in the group of men who received AndroGel 1.62% for one year.2
  • 78% (106/136) of patients who received AndroGel 1.62% for one year achieved an average serum testosterone level within the normal range (300–1000 ng/dL) on Day 364.2

  • Patients who received AndroGel 1.62% during the double-blind period and continued on active treatment during the open-label period are shown.

Study Design
Safety and efficacy of AndroGel 1.62% were assessed in an open-label, active treatment, non-comparative maintenance study. Safety and efficacy of AndroGel 1.62% were assessed in an open-label, active treatment, non-comparative maintenance study. 191 patients who completed the randomized, double-blind, parallel-group, placebo-controlled study (see above for original study design) entered the 182-day, open-label extension period. Patients could have received one of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily).2

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Safety Considerations2

Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk for a thromboembolic event.

Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.

Androgens may decrease blood glucose, and therefore insulin requirement in diabetic patients.

Monitor serum testosterrone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically.

AndroGel 1.62% clinical safety data

Supported by a 12-month clinical trial2

  • During the 182-day double-blind period:
    • Mean serum PSA concentration increased by 0.14 ng/mL for patients receiving AndroGel 1.62%.2
    • Mean serum PSA concentration decreased by 0.12 ng/mL for patients receiving placebo.2
  • During the 182-day open-label extension study:
    • Mean change in serum PSA values was 0.10 ng/mL for patients continuing on active therapy and patients transitioning onto active from placebo.2

Study Design
Multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men... Multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men with an average serum testosterone concentration <300 ng/dL as determined by two morning samples collected on the same day. Patients were initially randomized to receive 40.5 mg of AndroGel 1.62% or placebo. Patients returned to the clinic on days 14, 28, and 42 for predose serum total testosterone assessments, and their daily dose was titrated up or down in 20.25-mg increments if their level was outside the range of 350–750 ng/dL. Patients could have received one of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily) or placebo during the 182-day treatment period. The primary endpoint was the percentage of patients with an average serum testosterone level within the normal range (300–1000 ng/dL) on Day 112. Patients could agree to continue in an open-label, active-treatment maintenance period for an additional 182 days.2

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  • * PSA increased includes: PSA values that met pre-specified criteria for abnormal PSA values (an average change from baseline >0.75 ng/mL and/or an average PSA value >4.0 ng/mL based on 2 measurements) as well those reported as adverse events.
  • bEmotional lability includes: mood swings, affective disorder, impatience, anger, and aggression.
  • cContact dermatitis includes: 4 patients with dermatitis at non-application sites.

  • Other adverse reactions occurring in less than or equal to 2% of AndroGel 1.62%-treated patients and more frequently than placebo included: frequent urination and hyperlipidemia.2

Less than 2% of patients reported application site reactions2

  • During the 182-day double-blind period of the study, application site reactions occurred in less than 1% (2/234) of the patients receiving AndroGel 1.62%.2
  • In the 182-day open-label period of the study, 3 of 219 patients treated with AndroGel 1.62% reported application site reactions.2
  • No patients in the double-blind or open-label periods discontinued therapy due to application site reactions.2

Safety Considerations2

Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically.

 
 

Indication2,3

AndroGel® (testosterone gel) 1% and 1.62% CIII are androgens 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.
  • Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Important limitations of use: Safety and efficacy of AndroGel in males <18 years old have not been established.

Important Safety Information2,3

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel.
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
  • AndroGel is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are pregnant, may become pregnant, or are breastfeeding, as testosterone may cause fetal harm; or in men with known hypersensitivity to any of the ingredients in AndroGel.
  • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
  • Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens as appropriate. Monitor prostate specific antigen (PSA) levels periodically.
  • Avoid unintentional exposure of women or children to AndroGel. Secondary exposure to testosterone can produce signs of virilization and should be brought to the attention of the healthcare provider. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel should be promptly discontinued until the cause of virilization is identified.
  • Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
  • AndroGel is not indicated for use in women.
  • Treatment with AndroGel may lead to azoospermia; edema which may be serious in patients with preexisting cardiac, renal, or hepatic disease, or in patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
  • Treatment with androgens may lead to serious hepatic effects. AndroGel is not known to cause these adverse effects. Monitor liver function tests (LFTs) periodically.
  • Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid levels periodically.
  • Androgens should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
  • Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA). Most common adverse reactions for AndroGel 1% (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
  • Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.

Please see full Prescribing Information including BOXED WARNING and Medication Guide.

References: 1. Data on file, Abbott Laboratories. 2. AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories. 3. AndroGel 1% [package insert]. North Chicago, IL: Abbott Laboratories.