INDIANAPOLIS, June 28, 2011 /PRNewswire/ — Eli Lilly and
Company (NYSE:
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
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