Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study.
OBJECTIVE
We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level.


METHODS
This was a randomized, multicenter, double-blind, placebo controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range (300 to 1,050 ng/dl) upon treatment completion. We also assessed the impact of testosterone on sex drive and energy level measured using SAID (Sexual Arousal, Interest and Drive scale) and HED (Hypogonadism Energy Diary), respectively. A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency (decreased energy and/or decreased sexual drive) were randomized to 60 mg topical testosterone solution 2% or placebo once daily.


RESULTS
Of study completers 73% in the testosterone vs 15% in the placebo group had a testosterone level within the normal range at study end point (p <0.001). Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores (low sex drive subset p <0.001 vs placebo) and HED scores (low energy subset p = 0.02 vs placebo, not significant at prespecified p <0.01). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group. The incidence of increased hematocrit was higher with testosterone vs placebo (p = 0.04).


CONCLUSIONS
Once daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on HED though not at the prespecified p <0.01. No new safety signals were identified.
Department of Surgery, University of Western Ontario, London, Ontario, Canada. Electronic address: gebrock@sympatico.ca.
Gerald
G
Brock
Eli Lilly and Co., Indianapolis, Indiana.
Darell
D
Heiselman
Department of Clinical Physiopathology, University of Florence, Florence, Italy.
Mario
M
Maggi
Department of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea, Korea.
Sae Woong
SW
Kim
Urology Service, Hospital Infanta Leonor, Madrid, Spain.
José M
JM
Rodríguez Vallejo
Center for Reproductive Medicine and Andrology, University Hospital Halle (Saale), Halle, Germany.
Hermann M
HM
Behre
Quality of Life Medical and Research Center, Tucson, Arizona.
John
J
McGettigan
Eli Lilly and Co., Indianapolis, Indiana.
Sherie A
SA
Dowsett
Eli Lilly and Co., Indianapolis, Indiana.
Risa P
RP
Hayes
Eli Lilly and Co., Indianapolis, Indiana.
Jack
J
Knorr
Eli Lilly and Co., Indianapolis, Indiana.
Xiao
X
Ni
Eli Lilly and Co., Indianapolis, Indiana.
Kraig
K
Kinchen
D004311:Double-Blind Method; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000503:physiopathology*; D007989:Libido / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D012996:Solutions; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood*
D012996:Solutions; D013739:Testosterone
hypogonadism; questionnaires; testes; testosterone; treatment outcome