Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Original Article
  • Published:

Pharmacokinetics and drying time of testosterone 2% gel in men with hypogonadism: a multicenter, open-label, single-arm trial

International Journal of Impotence Research volume 27, pages 41–45 (2015)Cite this article

Subjects

Abstract

The objective of this study was to assess drying time after application of testosterone 2% gel (Fortesta Gel, Endo Pharmaceuticals), time needed for serum total testosterone (TT) to reach the eugonadal range (⩾300 ng dl–1), and time to steady-state serum TT. Thirty-four men with primary or secondary hypogonadism were enrolled in the study; 31 men were included in the pharmacokinetics (PKs) population. Testosterone 2% gel (40 mg) was applied once daily in the morning to the front and inner thighs for 14 days. Median gel drying time was 2.4 min (95% confidence interval (CI), 1.7–3.4 min; n=31). Serum TT concentrations reached the target eugonadal range with a median time of 2.9 h (95% CI, 1.9–4.3 h; n=24). Median time to steady-state serum TT concentration was 1.1 days (95% CI, 0.7–3.4 days; n=31). Six patients (17.6%; n=34) reported treatment-related adverse events; all were mild. The results from this 14-day PK study in men with hypogonadism suggest that testosterone 2% gel dries, on average, in <3 min after application and that testosterone 2% gel rapidly reaches the target eugonadal range and attains steady-state serum TT concentrations in about 1 day.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Figure 1
Figure 2
Figure 3

Similar content being viewed by others

References

  1. Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536–2559.

    Article  CAS  Google Scholar 

  2. Traish AM, Miner MM, Morgentaler A, Zitzmann M . Testosterone deficiency. Am J Med 2011; 124: 578–587.

    Article  CAS  Google Scholar 

  3. Darby E, Anawalt BD . Male hypogonadism: an update on diagnosis and treatment. Treat Endocrinol 2005; 4: 293–309.

    Article  CAS  Google Scholar 

  4. Rhoden EL, Morgentaler A . Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med 2004; 350: 482–492.

    Article  CAS  Google Scholar 

  5. Miner MM, Sadovsky R . Evolving issues in male hypogonadism: evaluation, management, and related comorbidities. Cleve Clin J Med 2007; 74: S38–S46.

    Article  Google Scholar 

  6. Lakshman KM, Basaria S . Safety and efficacy of testosterone gel in the treatment of male hypogonadism. Clin Interv Aging 2009; 4: 397–412.

    CAS  PubMed  PubMed Central  Google Scholar 

  7. Dandona P, Rosenberg MT . A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract 2010; 64: 682–696.

    Article  CAS  Google Scholar 

  8. Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C . Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract 2006; 60: 762–769.

    Article  CAS  Google Scholar 

  9. Corona G, Monami M, Rastrelli G, Aversa A, Sforza A, Lenzi A et al. Type 2 diabetes mellitus and testosterone: a meta-analysis study. Int J Androl 2011; 34: 528–540.

    Article  CAS  Google Scholar 

  10. Corona G, Monami M, Rastrelli G, Aversa A, Tishova Y, Saad F et al. Testosterone and metabolic syndrome: a meta-analysis study. J Sex Med 2011; 8: 272–283.

    Article  CAS  Google Scholar 

  11. Corona G, Rastrelli G, Monami M, Guay A, Buvat J, Sforza A et al. Hypogonadism as a risk factor for cardiovascular mortality in men: a meta-analytic study. Eur J Endocrinol 2011; 165: 687–701.

    Article  CAS  Google Scholar 

  12. Dohle G, Arver S, Bettocchi C, Kliesch S, Punab M, De Ronde W Guidelines on male hypogonadism.European Association of Urology. Available at http://www.uroweb.org/gls/pdf/17_Male_Hypogonadism_LR.pdf. (accessed 11 June 2013).

  13. Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ et al. Investigation, treatment, and monitoring of late-onset hypogonadism in males: ISA, ISSAM, and EAU recommendations. J Androl 2006; 27: 135–137.

    Article  CAS  Google Scholar 

  14. Nieschlag E, Behre HM, Bouchard P, Corrales JJ, Jones TH, Stalla GK et al. Testosterone replacement therapy: current trends and future directions. Hum Reprod Update 2004; 10: 409–419.

    Article  CAS  Google Scholar 

  15. Dobs AS, McGettigan J, Norwood P, Howell J, Waldie E, Chen Y . A novel testosterone 2% gel for the treatment of hypogonadal males. J Androl 2012; 33: 601–607.

    Article  CAS  Google Scholar 

  16. Miller J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ et al. Pharmacokinetics and relative bioavailability of absorbed testosterone after administration of a 1.62% testosterone gel to different application sites in men with hypogonadism. Endocr Pract 2011; 17: 574–583.

    Article  Google Scholar 

  17. Steidle C, Schwartz S, Jacoby K, Sebree T, Smith T, Bachand R . AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab 2003; 88: 2673–2681.

    Article  CAS  Google Scholar 

  18. Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM et al. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 2000; 85: 4500–4510.

    CAS  Google Scholar 

  19. Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A . Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf) 2011; 75: 836–843.

    Article  CAS  Google Scholar 

  20. Axiron (testosterone topical solution). Full Prescribing Information. Eli Lilly and Company: Indianapolis, IN, USA, 2011.

  21. AndroGel 1% (testosterone gel). Full Prescribing Information. AbbVie: North Chicago, IL, USA, 2013.

  22. Testim (testosterone gel). Full Prescribing Information. Auxilium Pharmaceuticals: Malvern, PA, USA, 2013.

  23. AndroGel 1.62% (testosterone gel). Full Prescribing Information. AbbVie: North Chicago, IL, USA, 2013.

  24. Fortesta (testosterone 2% gel for topical use). Full Prescribing Information. Endo Pharmaceuticals Solutions: Malvern, PA, USA, 2014.

  25. Hajjar RR, Kaiser FE, Morley JE . Outcomes of long-term testosterone replacement in older hypogonadal males: a retrospective analysis. J Clin Endocrinol Metab 1997; 82: 3793–3796.

    Article  CAS  Google Scholar 

  26. Rhoden EL, Morgentaler A . Symptomatic response rates to testosterone therapy and the likelihood of completing 12 months of therapy in clinical practice. J Sex Med 2010; 7: 277–283.

    Article  CAS  Google Scholar 

  27. Schoenfeld MJ, Shortridge E, Cui Z, Muram D . Medication adherence and treatment patterns for hypogonadal patients treated with topical testosterone therapy: a retrospective medical claims analysis. J Sex Med 2013; 10: 1401–1409.

    Article  CAS  Google Scholar 

  28. Marbury T, Hamill E, Bachand R, Sebree T, Smith T . Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel. Biopharm Drug Dispos 2003; 24: 115–120.

    Article  CAS  Google Scholar 

  29. Wang C, Berman N, Longstreth JA, Chuapoco B, Hull L, Steiner B et al. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: application of gel at one site versus four sites: a General Clinical Research Center Study. J Clin Endocrinol Metab 2000; 85: 964–969.

    CAS  PubMed  Google Scholar 

  30. Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab 2004; 89: 2085–2098.

    Article  CAS  Google Scholar 

  31. Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ et al. Effect of application site, clothing barrier, and application site washing on testosterone transfer with a 1.62% testosterone gel. Curr Med Res Opin 2012; 28: 281–290.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

This study was funded by Endo Pharmaceuticals, which also funded writing assistance to the authors, which was provided by Kristine Schuler, MS, and Amanda Kelly, MPhil, MSHN (Complete Healthcare Communications, Chadds Ford, PA) and by Peter Budka and Penny Butcher (Watermeadow Medical Whitney, UK).

Author information

Authors and Affiliations

  1. Men’s Health Boston, Brookline, MA, USA

    A Morgentaler

  2. Quality of Life Medical and Research Center, Tucson, AZ, USA

    J McGettigan

  3. Endo Pharmaceuticals, Malvern, PA, USA

    Q Xiang, T M Danoff & E M Gould

Authors
  1. A Morgentaler
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. J McGettigan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Q Xiang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. T M Danoff
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. E M Gould
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A Morgentaler.

Ethics declarations

Competing interests

AM is a consultant for Auxilium; a grant-recipient for Antares, Auxilium, Lilly and GSK; a lecturer for Auxilium, Bayer and Merck; and an investigator and speaker for Endo Pharmaceuticals. AM was also a principal investigator for Endo Pharmaceuticals for the following studies: EN3350-302, EN3324-201 and EN3369-302. JM is an investigator for Endo Pharmaceuticals. The Quality of Life Medical and Research Center, with which JM is affiliated, received grant and travel funding for the study. TMD, QX and EMG were employed by Endo Pharmaceuticals at the time the study was conducted and received stock and stock options as part of their compensation.

Additional information

Author contributions

TMD, QX, AM and EMG designed research; TMD, AM, EMG and JM conducted research; QX and TMD analyzed data; TMD, QX, EMG, JM and AM contributed to the content of the paper; AM had primary responsibility for final content. All authors read and approved the final manuscript.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Morgentaler, A., McGettigan, J., Xiang, Q. et al. Pharmacokinetics and drying time of testosterone 2% gel in men with hypogonadism: a multicenter, open-label, single-arm trial. Int J Impot Res 27, 41–45 (2015). https://doi.org/10.1038/ijir.2014.28

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/ijir.2014.28

Search

Advanced search

Quick links