Understanding the clinical safety data for AndroGel 1.62%1

The following safety data show adverse event rates from the 6-month clinical study. Please review the full Important Safety Information for AndroGel 1.62%.

Adverse reactions reported in >2% of patients taking AndroGel 1.62% and more frequently than with placebo in a 182-day, double-blind clinical trial1

AndroGel 1.62%(n=234)  % (n) Placebo(n=40)  %
PSA increaseda 11.1%(26) 0%
Emotional labilityb 2.6%(6) 0%
Hypertension 2.1%(5) 0%
Hematocrit or hemoglobin increased 2.1%(5) 0%
Contact dermatitisc 2.1%(5) 0%

aPSA (prostate specific antigen) 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 two measurements) as well as those reported as adverse events.

bEmotional lability includes: mood swings, affective disorder, impatience, anger, and aggression.

cContact dermatitis includes: four patients with dermatitis at non-application sites.

Other adverse reactions occurring in ≤2% of AndroGel 1.62%-treated patients and more frequently than placebo included frequent urination and hyperlipidemia.

Clinical study1,3:

  • Multicenter, randomized, double-blind, parallel-group, placebo-controlled
  • 274 hypogonadal men
  • Average serum testosterone concentration <300 ng/dL determined by two morning samples collected on the same day
  • Patients 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
  • 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 percent 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

Application site reactions for patients receiving AndroGel 1.62%1,4

Patients reporting application site reactions

182‑day double‑blind
period
182‑day open‑label
period
<1% (2/234) <2% (3/219)

In the double-blind and open-label trials, no patients discontinued therapy due to application site reactions.1

Open-label extension (OLE)1,4:

  • Safety and efficacy of AndroGel 1.62% were assessed
  • Open-label, active-treatment, non-comparative maintenance extension
  • 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 any of four AndroGel 1.62% doses (20.25 mg, 40.5 mg, 60.75 mg, or 81 mg daily)
  • The main outcome measure was the percent of men achieving an average serum total testosterone concentration over a 24-hour dosing interval (Cav) within the normal range of 300-1000 ng/dL on Day 364

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, 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.
  • Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as AndroGel. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue AndroGel and initiate appropriate workup and management.
  • Some studies, but not all, have reported an increased risk of major cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel.