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Hypogonadal Men Nonresponders to the PDE5 Inhibitor Tadalafil Benefit from Normalization of Testosterone Levels with a 1% Hydroalcoholic Testosterone Gel in the Treatment of Erectile Dysfunction (TADTEST Study)
Abstract
Introduction: Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. Aims: To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. Methods: A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45–80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures: Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). Results: Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤3 ng/mL. Conclusions: The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤3 ng/mL.
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“a panel of experts at the International Consultation on Erectile Dysfunction recommended oral agents as a first-line treatment for ED independent of etiology.2”
From Treatment Strategy for Non-Responders to PDE5 Inhibitors (2013) · cites this paper as [2]
In the citing paper
“The lower the baseline testosterone level, the better is the effect.”
From Treatment Strategy for Non-Responders to PDE5 Inhibitors (2013) · cites this paper as [2]
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“The TADTEST study revealed that addition of testosterone to treatment with PDE5 inhibitors is beneficial in men with low baseline testosterone levels (<3 ng/ml).2”
From Treatment Strategy for Non-Responders to PDE5 Inhibitors (2013) · cites this paper as [2]
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Cited by
Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline.
Bhasin, S., Brito, J. P., Cunningham, G. R., Hayes, F. J., Hodis, H. N., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., Wu, F. C., & Yialamas, M. A. (2018) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2018-00229 · Cited by 1,736
Corona, G., Goulis, D. G., Huhtaniemi, I., Zitzmann, M., Toppari, J., Forti, G., Vanderschueren, D., & Wu, F. C. (2020) · Andrology · doi:10.1111/andr.12770 · Cited by 431
Update: Hypogonadotropic Hypogonadism in Type 2 Diabetes and Obesity
Dandona, P., & Dhindsa, S. (2011) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2010-2724 · Cited by 313
Corona, G., Maseroli, E., Rastrelli, G., Isidori, A. M., Sforza, A., Mannucci, E., & Maggi, M. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2014.950653 · Cited by 297
Self-citationTestosterone supplementation and sexual function: A meta-analysis study
Corona, G., Isidori, A. M., Buvat, J., Aversa, A., Rastrelli, G., Hackett, G., Rochira, V., Sforza, A., Lenzi, A., Mannucci, E., et al. (2014) · The Journal of Sexual Medicine · doi:10.1111/jsm.12536 · Cited by 263
Self-citation
Metadata
- Authors
- Buvat, J., Montorsi, F., Maggi, M., Porst, H., Kaipia, A., Colson, M. H., Cuzin, B., Moncada, I., Martin-Morales, A., Yassin, A., Meuleman, E., Eardley, I., Dean, J. D., & Shabsigh, R.
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-01-01
- Volume
- 8
- Issue
- 1
- Pages
- 284-293
- ISSN
- 1743-6109
- 1743-6095
- Cited by
- 131
- References
- 7
- Language
- en
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