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)

Jacques Buvat, Francesco Montorsi, Mario Maggi, Hartmut Porst, Antti Kaipia, Marie Helène Colson, Beatrice Cuzin, Ignacio Moncada, Antonio Martin-Morales, Aksam Yassin, Eric Meuleman, Ian Eardley, John Daniel Dean, Ridwan Shabsigh

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)284-293
Number of pages10
JournalJournal of Sexual Medicine
Volume8
Issue number1
DOIs
Publication statusPublished - Jan 2011

Fingerprint

Phosphodiesterase 5 Inhibitors
Erectile Dysfunction
Testosterone
Gels
Placebos
Therapeutics
Coitus
1-testosterone
Tadalafil
Outcome Assessment (Health Care)
Population

Keywords

  • Combined therapy
  • Erectile dysfunction
  • Nonresponders
  • Phosphodiesterase type 5 inhibitors
  • Tadalafil once a day
  • Testosterone therapy

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynaecology
  • Reproductive Medicine

Cite this

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). / Buvat, Jacques; Montorsi, Francesco; Maggi, Mario; Porst, Hartmut; Kaipia, Antti; Colson, Marie Helène; Cuzin, Beatrice; Moncada, Ignacio; Martin-Morales, Antonio; Yassin, Aksam; Meuleman, Eric; Eardley, Ian; Dean, John Daniel; Shabsigh, Ridwan.

In: Journal of Sexual Medicine, Vol. 8, No. 1, 01.2011, p. 284-293.

Research output: Contribution to journalArticle

Buvat, Jacques ; Montorsi, Francesco ; Maggi, Mario ; Porst, Hartmut ; Kaipia, Antti ; Colson, Marie Helène ; Cuzin, Beatrice ; Moncada, Ignacio ; Martin-Morales, Antonio ; Yassin, Aksam ; Meuleman, Eric ; Eardley, Ian ; Dean, John Daniel ; Shabsigh, Ridwan. / 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). In: Journal of Sexual Medicine. 2011 ; Vol. 8, No. 1. pp. 284-293.
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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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AU - Buvat, Jacques

AU - Montorsi, Francesco

AU - Maggi, Mario

AU - Porst, Hartmut

AU - Kaipia, Antti

AU - Colson, Marie Helène

AU - Cuzin, Beatrice

AU - Moncada, Ignacio

AU - Martin-Morales, Antonio

AU - Yassin, Aksam

AU - Meuleman, Eric

AU - Eardley, Ian

AU - Dean, John Daniel

AU - Shabsigh, Ridwan

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N2 - 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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