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Cited by 109Hormonal and reproductive studiesAdrenal Hormones and DisordersSexual function and dysfunction studies

Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study

Brock, Gerald, Heiselman, Darell, Maggi, Mario, Kim, Sae Woong, Rodríguez Vallejo, José M., Behre, Hermann M., McGettigan, John, Dowsett, Sherie A. +4 more·2016·Journal of Urology
DOI 10.1016/j.juro.2015.10.083
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Abstract

PURPOSE: We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level. MATERIALS AND 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.

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Crossref · 10.1016/j.juro.2015.10.083

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  • Randomized controlled trials have shown no significant increase in the rate of prostate cancer diagnosis in older, testosterone deficient men treated with testosterone compared to placebo.

    “Randomized controlled trials have shown that there is not a significant increase in the rate of a prostate cancer diagnosis in older, testosterone deficient men who were treated with testosterone compared to placebo.”

    From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [30]

  • The evidence is less conclusive as to whether testosterone therapy improves cognitive function, measures of diabetes, energy, fatigue, lipid profiles, and quality of life measures.

    “The evidence is less conclusive as to whether or not testosterone therapy improves cognitive function, 28 measures of diabetes, 29 energy, 30 fatigue, 30 lipid profiles, 29 and quality of life measures. 31”

    From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [30]

  • There is accumulating evidence against a link between testosterone therapy and prostate cancer development.

    “there is accumulating evidence against a link between testosterone therapy and prostate cancer development.”

    From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [30]

  • Testosterone therapy improves bone mineral density, lean body mass, erectile function, and anemia.

    “Though testosterone therapy improves bone mineral density, lean body mass, erectile function, and anemia, there is inconclusive evidence on the benefits of testosterone therapy on cognitive function, energy levels, blood glucose or lipid levels, and controversy remains around whether testosterone therapy affects the risk of cardiovascular events (6-13).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [10]

  • Evidence is inconclusive on the benefits of testosterone therapy on cognitive function, energy levels, blood glucose or lipid levels.

    “Though testosterone therapy improves bone mineral density, lean body mass, erectile function, and anemia, there is inconclusive evidence on the benefits of testosterone therapy on cognitive function, energy levels, blood glucose or lipid levels, and controversy remains around whether testosterone therapy affects the risk of cardiovascular events (6-13).”

    From Non-testosterone management of male hypogonadism: an examination of the existing literature (2020) · cites this paper as [10]

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Authors
Brock, G., Heiselman, D., Maggi, M., Kim, S. W., Rodríguez Vallejo, J. M., Behre, H. M., McGettigan, J., Dowsett, S. A., Hayes, R. P., Knorr, J., Ni, X., & Kinchen, K.
Affiliations
  • Western University (CA)
  • Eli Lilly (United States) (US)
  • University of Florence (IT)
  • The Catholic University of Korea Seoul St. Mary's Hospital (KR)
  • Urology Service, Hospital Infanta Leonor, Madrid, Spain
  • University Hospital in Halle (DE)
  • Quality of Life Medical and Research Center, Tucson, Arizona
ORCID
Venue
Journal of Urology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2016-03
Volume
195
Issue
3
Pages
699-705
ISSN
  • 0022-5347 (ISSN-L)
  • 1527-3792
DOI
10.1016/j.juro.2015.10.083
OpenAlex
W1818591415
Cited by
109
References
30
Citations by year
2026: 3 · 2025: 8 · 2024: 12 · 2023: 7 · 2022: 11 · 2021: 12 · 2020: 9 · 2019: 10 · 2018: 13 · 2017: 13 · 2016: 10
FWCI
10.40
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Journal of Urology (publishedVersion)
  • PubMed (publishedVersion)
  • Florence Research (University of Florence) (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Keywords
testosterone replacement therapy, hypogonadism, androgen deficiency, sexual desire, energy levels, hematocrit, cardiovascular safety
MeSH terms
Double-Blind Method, Humans, Hypogonadism, Libido, Male, Middle Aged, Solutions, Testosterone

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