Results at Day 3641,3
Following the 6-month, placebo-controlled clinical study, an open-label extension was commenced. The main outcome measure for this extension was the percent of men achieving an average serum total testosterone concentration (Cav) within the normal range of 300-1000 ng/dL on Day 364.1,3 Key findings included:
- 78% (106/136) of men who continued on AndroGel 1.62% were within average normal serum testosterone range on Day 3643
- Mean (SD) total testosterone concentration for patients continuing on AndroGel 1.62% on Day 364 was 455 ng/dL (+/-192 ng/dL)1
Number of subjects achieving target range (300-1000 ng/dL) for testosterone Cav by Day 3643
95% Cl, 70.0 -84.6
95% Cl, 66.4 -97.2
95% Cl, 72.1 -85.3
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 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 364.1,3
- 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).