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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).
- Source :
-
The journal of sexual medicine [J Sex Med] 2011 Jan; Vol. 8 (1), pp. 284-93. - Publication Year :
- 2011
-
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.<br />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.<br />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).<br />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.<br />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.<br /> (© 2010 International Society for Sexual Medicine.)
- Subjects :
- Administration, Topical
Aged
Aged, 80 and over
Analysis of Variance
Double-Blind Method
Drug Therapy, Combination
Humans
Hydrogels
Intention to Treat Analysis
Male
Middle Aged
Tadalafil
Testosterone adverse effects
Carbolines administration & dosage
Erectile Dysfunction drug therapy
Hormone Replacement Therapy adverse effects
Hypogonadism drug therapy
Phosphodiesterase 5 Inhibitors administration & dosage
Testosterone administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1743-6109
- Volume :
- 8
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The journal of sexual medicine
- Publication Type :
- Academic Journal
- Accession number :
- 20704642
- Full Text :
- https://doi.org/10.1111/j.1743-6109.2010.01956.x