title: The Effect of Testosterone Topical Solution in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel.
abstract: This study evaluated the effect of axillary administration of a 2% testosterone solution (Axiron®) in hypogonadal (HGN) men who had had a suboptimal response to treatment with a commercially available topical testosterone gel. HGN men averaging 57 years old, with a mean body mass index of 31.9 kg/m2and median baseline testosterone level (T-level) of 185.2 ng/dL, who had failed to reach normal T-levels with a topical testosterone gel (Androgel 1.62%, Androgel, Testim, or Fortesta) were treated with a 2% testosterone solution until T-levels reached a normal range (from ≥300 to ≤1,050 ng/dL) or for up to 9 weeks. Outcomes included the cumulative percentage of men with a serum T-level in the normal range during treatment with Axiron and improvement in symptoms of low energy level and low sexual drive. During the study, 95% of HGN men (72/78) attained a T-level in the normal range. The median T-level at endpoint was 495.7 ng/dL, a threefold increase over baseline, p < .001, 70% achieving normal T-levels within the first 2 weeks of treatment. In a post hoc analysis, all subjects with baseline body mass indexes >35 kg/m2( n = 19) achieved T-levels in the normal range. Prior to treatment, over 61% of subjects (48/78) reported impairment in either energy level or sexual drive. After treatment (or testosterone normalization), energy level improved in 75% of subjects and sexual drive improved in 70%. Topical 2% testosterone solution is a safe and effective treatment for HGN men who have had a suboptimal response to previous treatment with topical testosterone gels.
authors.affiliation: 1 Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Patrick R
authors.initials: PR
authors.lastname: Burns
authors.affiliation: 2 University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.
authors.forename: Edward D
authors.initials: ED
authors.lastname: Kim
authors.affiliation: 1 Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Dustin D
authors.initials: DD
authors.lastname: Ruff
authors.affiliation: 3 Cooper Medical School of Rowan University, Camden, NJ, USA.
authors.forename: Allen D
authors.initials: AD
authors.lastname: Seftel
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000728:Androgens / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005782:Gels; D020249:Hormone Replacement Therapy / Q000379:methods; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000097:blood*
chemical_list: D000728:Androgens; D005782:Gels; D013739:Testosterone
keywords: hormone replacement therapy; male reproductive health; testosterone solution