Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

  • participants needed
  • sponsor
    Hospital Santa Fe
Updated on 7 November 2020


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.

Condition Impotence
Treatment Testosterone Undecanoate and/or PDE-5
Clinical Study IdentifierNCT00555087
SponsorHospital Santa Fe
Last Modified on7 November 2020


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