Restore and maintain testosterone levels with AndroGel 1%

Testosterone levels over 180 days of AndroGel 1% treatment1-3

Baseline testosterone levels were 187.4 ng/dL for 100 mg AndroGel 1% (n=78) and 185.8 ng/dL for 50 mg
AndroGel 1% (n=73)

  • Patients (n=37) on 75 mg AndroGel 1% had a mean total testosterone concentration of 601 +/- 309 ng/dL on day 180.1

Study Design

Randomized, multicenter (16 centers), parallel study comparing defined efficacy parameters of 50 mg and 100 mg AndroGel 1% and a testosterone patch in 227 hypogonadal men over a 180-day treatment period. Patients on AndroGel 1% who had testosterone levels above or below the normal range on day 60 were titrated to 75 mg on day 91.3

  • 87% of patients who were appropriately titrated with AndroGel 1% (n=129) achieved an average serum testosterone level within the normal range on treatment day 180.2
  • During the study, significant increases in hemoglobin/hematocrit and PSA levels occurred. Mean serum PSA concentration was shown to increase by 0.26 ng/mL (P<0.001) during the initial 6-month study with no further statistical increase from 6 months through 36 months. An increase in serum PSA levels occurred in approximately 18% of individual patients in a 3-year extension study.1,3,4

Safety Considerations1

  • Monitor serum testosterone, prostate-specific antigen, hemoglobin, hematocrit, liver function test, and lipid levels periodically.
  • Most common adverse reactions of AndroGel 1% (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
  • Do not apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back.