Erectile Dysfunction Clinical Trial
Official title:
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.
The main objective of this study is to evaluate the response of erectile dysfunction in
hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of
the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.
Secondary Study Objectives
- To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA,
lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal
digital examination.
- To Determinate physiologic reconstitution in patients under treatment by means of total
and free testosterone dosage.
The importance of testosterone in desire, interest and sexual motivation is well known, but
its effects on erectile function continue provoking controversy. Data obtained in animals
under experimental or surgical castration, explains how this condition can cause a
veno-occlusive dysfunction and therefore an erectile dysfunction. In a model of animal
flebogenous erectile dysfunction, the intracavernous vascular endothelial growth factor
(VEGF), together with testosterone, reestablishes the balance between the muscle and the
conjunctive tissue, hypertrophy and hyperplasia of endothelial cells and regularizes the
diameter of dorsal nervous cells, thus preventing the veno-occlusive dysfunction. Castration
also induces the apopthosis in the erectile tissue of the penis; the treatment with
testosterone provokes a new DNA synthesis.
There are certain indicators that the treatment with testosterone could help patients with
erectile dysfunction and low testosterone base line amounts. Likewise, androgens could
control the expression and the activity of type 5 phosphodiesterase (PDE-5) of the cavernous
body of the penis.
Pharmacological treatment with PDE-5 inhibitors, administered orally fails in certain cases
of erectile dysfunction, even more in hypogonadal males. Some studies show that the
combination of testosterone with a PDE-5 inhibitor helps the recovery of sexual function in
patients; therefore, giving the possibility of a combined pharmacological treatment with
testosterone in erectile dysfunction.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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