Eli Lilly: Newly Published Study Showed Axiron Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men

Eli Lilly and Company LLY announced that a pivotal Phase III Axiron study, published on the Clinical Endocrinology website, showed that Axiron® (testosterone) topical solution CIII, when applied to the underarm, met the primary study objective to restore testosterone levels to the normal range (300 – 1050 ng/dL) in men with low testosterone. In addition, secondary outcomes showed that the treatment of Axiron improved symptoms associated with low testosterone. Testosterone deficiency, also known as hypogonadism or low testosterone, is a clinical condition in which the testicles, hypothalamus or pituitary gland is affected by disease or damage that results in inhibiting hormone secretion and testosterone production.(i) About the Study The Phase III open label, 120-day clinical study, conducted in 26 centers throughout the world, assessed the safety, pharmacokinetics and efficacy of a 2% formulation of testosterone topical solution (Axiron) applied daily to the underarm. All 155 men began the study on a 60 mg dose and had their dose adjusted on Days 45 and 90, if necessary, to maintain their testosterone levels within the physiological range based on an average serum testosterone levels tested on Days 15 and 60, respectively. On Day 120, of the 138 men for which there was evaluable data, 84% had an average testosterone concentration within the normal range (300-1050 ng/dL). On Day 120, the majority of the men, 97 subjects, remained on 60 mg starting dose; three men were on 30 mg; 25 men were on 90 mg; and 10 men were on 120 mg. The study also assessed the effect of treatment on symptoms associated with low testosterone as measured by the Psychosexual Daily Questionnaire. Improvement in sexual desire and activity were apparent as early as 15 days (1.9 and 0.93 point improvement, respectively, both P<0.0001) and were sustained throughout the study (3.36 and 1.84 point, respectively, both P<0.0001). There were also statistically significant improvements from baseline in erection maintained for satisfactory duration, positive mood and negative mood (4.29, 4.86 and 1.44 point, respectively, all P<0.0001). Additionally, the study evaluated the effect of treatment on men's general well-being as measured by the SF-36 questionnaire. There were significant mean changes from baseline to Day 120 on both the SF-36 Physical Component and SF-36 Mental Component scores (1.55 point, p=0.0254 and 4.54 point, p<0.0001, respectively).