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Newly Published Study Showed Axiron® (testosterone) Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men
Date:6/28/2011

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).

Since Axiron is applied to the underarm, the study also evaluated the potential impact of the use of deodorants or antiperspirant and of washing the application area. Among those who completed 120 days of treatment, the proportion of men with testosterone levels in the normal range was similar among those who used deodorant or antiperspirant since the last visit (83.3%); those who used deodorant or antiperspirant every day since the last visit (83.1%); those who did not use any deodorant or antiperspirant since the last visit (88.3%); and those who did not use deodorant or antiperspirant every day since the last visit (88.3%). At the end of the study, Day 120, among men (n=34) who reported showering/washing the application site at least two hours or more after Axiron application during the 24-hour sampling period, 82.4% had testosterone levels within the normal range compared to 86.9% of men (n=99) who reported not showering/washing the application site during the 24-hour sampling period.

The most common adverse reactions reported during the study were application site reaction (7.7%), application site redness (5.2%), headache (5.2%), increased red blood cell count (3.9%), nasopharyngitis (3.9%), diarrhea (2.6%), and vomiting (2.6%). Additionally, there was an increa
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SOURCE Eli Lilly and Company
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