CLINICAL STUDY & OLE

In a 6-month clinical study, AndroGel 1.62% restored testosterone levels in men with hypogonadism

The 6-month study was specifically set up to assess pre-determined titration points at Days 14, 28, and 42. During the 6 months, 74% of patients were titrated due to below- or above-normal pre-dose serum total testosterone.3

The primary endpoint for this AndroGel 1.62% clinical study was the percentage of men achieving an average pre-dose serum total testosterone level within the average normal serum range* (300-1000 ng/dL) on Day 112.1

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On Day 112, AndroGel 1.62% had raised testosterone to the average normal serum range* in 82% of men who used it daily, versus 37% who used placebo.* On the same day, the mean (SD) serum testosterone concentration for all doses was 561 ng/dL (+/-259 ng/dL).1,3

*P< 0.0001

Study Design:

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.1,3

Safety Considerations1

  • 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 of thromboembolic events. Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically.
  • Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products such as AndroGel 1.62%. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue AndroGel 1.62% and initiate appropriate workup and management.

Open-label extension main outcome measure

Results at Day 3641,4

Following the 6-month, placebo-controlled clinical study, an open-label extension was begun. The main outcome measure for this extension was the percentage of men achieving an average serum total testosterone concentration (Cavg) within the normal range of 300-1000 ng/dL on Day 364.1,4 Key findings included:

  • 78% (106/136) of men who continued on AndroGel 1.62% within average normal serum testosterone range on Day 3644
  • Mean (SD) total testosterone concentration for patients continuing on AndroGel 1.62% Day 364 was 455 ng/dL (+/-192 ng/dL)1

OLE Details:

Safety and efficacy of AndroGel 1.62% were assessed in an open-label, active-treatment, non-comparative maintenance extension. 191 patients who completed the randomized, double-blind, parallel-group, placebo-controlled study (see 6-month clinical study 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 percentage of men achieving an average serum total testosterone concentration over a 24-hour dosing interval (Cavg) within the normal range of 300-1000 ng/dL on Day 364.1,4

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).