HCP Efficacy and Safety | AndroGel (testosterone gel) 1.62%

EFFICACY
CLINICAL SAFETY

AndroGel 1.62% restores testosterone levels

Pivotal study

Primary endpoint: 82% of patients who were treated with AndroGel 1.62% achieved an average predose serum total testosterone level within the normal range on Day 112 vs 37% of hypogonadal men who were treated with placebo (p<0.0001).¹

AndroGel 1.62% pivotal trial efficacy results

^a40.5 mg daily dose.

^b20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily doses.

Pivotal Study Design

Pivotal study: 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 matching 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 any 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.^1,2

Full study design details

Safety Considerations¹

AndroGel 1.62% is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are or may become pregnant, or are breastfeeding, as testosterone may cause fetal harm.

AndroGel 1.62% is not indicated for use in women.

Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA).

AndroGel 1.62% clinical safety data from a 12-month clinical trial¹

During the 182-day double-blind period:
- Mean serum PSA concentration increased by 0.14 ng/mL for patients receiving AndroGel 1.62%.¹
- Mean serum PSA concentration decreased by 0.12 ng/mL for patients receiving placebo.¹
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 therapy from placebo.¹

Designs

Pivotal and Open-label extension study designs...

Pivotal study: 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 matching placebo. Patients returned to the clinic on Days 14, 28, and 42 for pre-dose 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 any 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.^1,2

Open-label extension study: Safety and efficacy of AndroGel 1.62% were assessed in an open-label, active-treatment, noncomparative maintenance study. 191 patients who completed the randomized, double-blind, parallel-group, placebo-controlled study entered the 182-day open-label extension period. Patients could have received any of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily).¹

Full study design details

^aPSA 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 as 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.¹

2% of patients reported application site reactions¹

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%.¹
In the 182-day open-label period of the study, 3 of 219 additional patients treated with AndroGel 1.62% reported application site reactions.
No patients in the double-blind or open-label periods discontinued therapy due to application site reactions.

Safety Considerations¹

Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH.
Treatment with AndroGel 1.62% may lead to azoospermia; edema 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.

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Indication^1,3
AndroGel^® 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 or hypogonadotropic hypogonadism (congenital or acquired).

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.

Understand the difference

AndroGel 1.62%
dosing and
application *At the starting dose.

Patient access^†

Indication^1,3

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 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.

Important Safety Information^1,3

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 or may become pregnant, or are breastfeeding, as testosterone may cause fetal harm.
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. 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 concentrations 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 of 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.

^†Eligible patients will save up to $50 off their monthly AndroGel 1.62% prescription after their $10 co-pay for a total of 12 transactions (a total of $600 savings). This program is not valid for prescriptions reimbursed under Medicare, Medicaid, or similar federal or state programs. Abbott Laboratories reserves the right to rescind, revoke, or amend this offer without notice.

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

References: 1. AndroGel 1.62% [package insert]. North Chicago, IL: Abbott Laboratories. 2. Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011;8:2079-2089. 3. AndroGel 1% [package insert]. North Chicago, IL: Abbott Laboratories.

Androgel 1.62%: Designed with a Man in Mind

AndroGel 1.62% restores testosterone levels

Pivotal study

Pivotal Study Design

Safety Considerations1

AndroGel 1.62% clinical safety data from a 12-month clinical trial1

Designs

2% of patients reported application site reactions1

Safety Considerations1

Safety Considerations¹

AndroGel 1.62% clinical safety data from a 12-month clinical trial¹

2% of patients reported application site reactions¹

Safety Considerations¹