Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men
Abstract
Introduction: Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels. Aim: To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days. Methods: This was a multicenter, randomized, double-blind, placebo-controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate-specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42. Main Outcome Measures: The percentage of subjects with serum total testosterone average concentrations (Cav) within the normal range of 300–1,000 ng/dL on study days 14, 56, 112, and 182. Results: Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone Cav values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated. Conclusions: In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels.
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Common testosterone therapies normalize total testosterone to eugonadal levels in approximately 75-85% of men, indicating a 15-25% rate of suboptimal response.
“Common T therapies result in normalization of TT to eugonadal levels in approximately 75–85% of men, indicating a 15–25% rate of suboptimal response.138, 139”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [138]
Cites
Longitudinal Effects of Aging on Serum Total and Free Testosterone Levels in Healthy Men
Harman, S. M., Metter, E. J., Tobin, J. D., Pearson, J., & Blackman, M. R. (2001) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.86.2.7219 · Cited by 2,760 · see citing works
Adverse Events Associated with Testosterone Administration
Basaria, S., Coviello, A. D., Travison, T. G., Storer, T. W., Farwell, W. R., Jette, A. M., Eder, R., Tennstedt, S., Ulloor, J., Zhang, A., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1000485 · Cited by 1,494 · see citing works
Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M. (2006) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2005-2847 · Cited by 965 · see citing works
Risks of testosterone-replacement therapy and recommendations for monitoring.
Rhoden, E. L., & Morgentaler, A. (2004) · New England Journal of Medicine · doi:10.1056/nejmra022251 · Cited by 705 · see citing works
Wang, C., Cunningham, G., Dobs, A., Iranmanesh, A., Matsumoto, A. M., Snyder, P. J., Weber, T., Berman, N., Hull, L., & Swerdloff, R. S. (2004) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2003-032006 · Cited by 656 · see citing works
Testosterone replacement therapy improves mood in hypogonadal men--a clinical research center study
Wang, C., Alexander, G. M., Berman, N., Salehian, B., Davidson, T., McDonald, V., Steiner, B., Hull, L., Callegari, C. C., & Swerdloff, R. S. (1996) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.81.10.8855804 · Cited by 453 · see citing works
Steidle, C. P., Schwartz, S. L., Jacoby, K., Sebree, T. B., Smith, T. P. L., & Bachand, R. T. (2003) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2002-021058 · Cited by 406 · see citing works
Dobs, A. S. (1999) · Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.84.10.3469 · Cited by 381 · see citing works
Effects of Androgen on Sexual Behavior in Hypogonadal Men
Davidson, J. M., Camargo, C. A., & Smith, E. R. (1979) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem-48-6-955 · Cited by 367 · see citing works
Wang, C. (2000) · Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.85.8.2839 · Cited by 359 · see citing works
Long-Term Pharmacokinetics of Transdermal Testosterone Gel in Hypogonadal Men 1
Swerdloff, R. S., Wang, C., Cunningham, G. R., Dobs, A. S., Iranmanesh, A., Matsumoto, A. M., Snyder, P. J., Weber, T. J., Longstreth, J. A., & Berman, N. (2000) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.85.12.7045 · Cited by 343 · see citing works
KWAN, M., GREENLEAF, W. J., MANN, J., CRAPO, L., & DAVIDSON, J. M. (1983) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem-57-3-557 · Cited by 339 · see citing works
Skakkebæk, N. E., Bancroft, J., DAVIDSON, D. W., & Warner, P. (1981) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1981.tb00364.x · Cited by 335 · see citing works
Long-Term Pharmacokinetics of Transdermal Testosterone Gel in Hypogonadal Men
Swerdloff, R. S. (2000) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.85.12.4500 · Cited by 262 · see citing works
Matsumoto, A. M., Sandblom, R. E., Schoene, R. B., Lee, K. A., Giblin, E. C., Pierson, D. J., & Bremner, W. J. (1985) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1985.tb00161.x · Cited by 246 · see citing works
Bhasin, S., Singh, A. B., Mac, R. P., Carter, B., Lee, M. I., & Cunningham, G. R. (2003) · Journal of Andrology · doi:10.1002/j.1939-4640.2003.tb02676.x · Cited by 219 · see citing works
Wang, C., Berman, N., Longstreth, J. A., Chuapoco, B., Hull, L., Steiner, B., Faulkner, S., Dudley, R. E., & Swerdloff, R. S. (2000) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.85.3.6437 · Cited by 189 · see citing works
McNicholas, T. A., Dean, J. D., Mulder, H., Carnegie, C., & Jones, N. A. (2003) · BJU International · doi:10.1046/j.1464-410x.2003.04016.x · Cited by 178 · see citing works
O’Carroll, R. E., Shapiro, C. M., & Bancroft, J. (1985) · Clinical Endocrinology · doi:10.1111/j.1365-2265.1985.tb01113.x · Cited by 178 · see citing works
Wang, C. E., Swerdloff, R. S., Iranmanesh, A., Dobs, A. S., Snyder, P. J., Cunningham, G. R., Matsumoto, A. M., Weber, T. J., Berman, N., & the Testosterone Gel Study Group (2001) · Clinical Endocrinology · doi:10.1046/j.1365-2265.2001.01271.x · Cited by 176 · see citing works
Gooren, L. J., Behre, H. M., Saad, F., Frank, A., & Schwerdt, S. (2007) · The Aging Male · doi:10.1080/13685530701600885 · Cited by 59 · see citing works
Testosterone replacement in men with andropause: an overview.
Brawer, M. K. (2004) · Europe PMC (PubMed Central) · Cited by 43 · see citing works
Treatment of Symptomatic Androgen Deficiency Results From the Boston Area Community Health Survey
Hall, S. A. (2008) · Archives of Internal Medicine · doi:10.1001/archinte.168.10.1070 · Cited by 39 · see citing works
Miller, J. L., Britto, M. R., Fitzpatrick, S. B., McWhirter, C. L., Testino, S. A., Brennan, J. J., & ZumBrunnen, T. L. (2011) · Endocrine Practice · doi:10.4158/ep10192.or · Cited by 25 · see citing works
Self-citationSiddique, H., Smith, J. C., & Corrall, R. J. M. (2003) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2004.01933.x · Cited by 16 · see citing works
Androgen replacement in the male: recent studies
Hayes, F. J. (2001) · Current Opinion in Endocrinology & Diabetes · doi:10.1097/00060793-200112000-00007 · Cited by 6 · see citing works
Evolution of delivery systems for testosterone administration
Kaufman, J. M. (2004) · Current Sexual Health Reports · doi:10.1007/s11930-004-0025-0 · Cited by 2 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
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Corona, G., Rastrelli, G., Di Pasquale, G., Sforza, A., Mannucci, E., & Maggi, M. (2018) · The Journal of Sexual Medicine · doi:10.1016/j.jsxm.2018.04.641 · Cited by 138 · see citing works
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., et al. (2016) · Journal of Urology · doi:10.1016/j.juro.2015.10.083 · Cited by 109 · see citing works
Trost, L. W., & Mulhall, J. P. (2016) · The Journal of Sexual Medicine · doi:10.1016/j.jsxm.2016.04.068 · Cited by 98 · see citing works
Emerging medication for the treatment of male hypogonadism
Corona, G., Rastrelli, G., Vignozzi, L., & Maggi, M. (2012) · Expert Opinion on Emerging Drugs · doi:10.1517/14728214.2012.683411 · Cited by 93 · see citing works
- Authors
- Kaufman, J. M., Miller, M. G., Garwin, J. L., Fitzpatrick, S., McWhirter, C., & Brennan, J. J.
- Affiliations
- Urology Research Options , Aurora, CO , USA
- Abbott (United States) (US)
- GlaxoSmithKline (United States) (US)
- MedImmune, LLC. , Gaithersburg, MD , USA
- Corresponding author
- Kaufman, Joel M.
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-07-01
- Volume
- 8
- Issue
- 7
- Pages
- 2079-2089
- ISSN
- 1743-6095 (ISSN-L)
- 1743-6109
- OpenAlex
- W1954262186
- Cited by
- 70
- References
- 27
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 4 · 2022: 5 · 2021: 3 · 2020: 2 · 2019: 3 · 2018: 5 · 2017: 6 · 2016: 7 · 2015: 9 · 2014: 7 · 2013: 5 · 2012: 6
- FWCI
- 5.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- The Journal of Sexual Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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 › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone gel, topical testosterone, male hypogonadism, testosterone replacement therapy, serum total testosterone, dose titration, skin permeation, treatment safety
- MeSH terms
- Administration, Topical, Adult, Aged, Androgens, Dose-Response Relationship, Drug, Double-Blind Method, Gels, Humans, Hypogonadism, Male, Middle Aged, Testosterone, Treatment Outcome
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