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Sponsors and Collaborators: |
Hospital Santa Fe Bayer |
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Information provided by: | Hospital Santa Fe |
ClinicalTrials.gov Identifier: | NCT00555087 |
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
Condition | Intervention | Phase |
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Erectile Dysfunction Hypogonadotrophic Males |
Drug: Testosterone Undecanoate and/or PDE-5 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV. |
Estimated Enrollment: | 50 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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A= Nebido: Experimental
It is and intervention study with 1 arm
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Drug: Testosterone Undecanoate and/or PDE-5
Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jorge G Jaspersen, MD-Urology | (5255) 55 64 53 70 | jaspersen@prodigy.net.mx |
Contact: Lauro G Gomez, MD | (5255) 818 2204 444 | laurogomez@hotmail.com |
Mexico, D.F. | |
Hospital Santa Fe | Not yet recruiting |
Mexico city, D.F., Mexico, 06700 | |
Contact: Jorge G Jaspersen, MD-Urology (5255) 55 64 53 70 jaspersen@prodigy.net.mx | |
Mexico, Jalisco | |
Hospital General de Occidente | Not yet recruiting |
Guadalajara, Jalisco, Mexico, 44690 | |
Contact: Arturo R Rodriguez, MD-Urology (5255) 333 5879 090 aruro2000@yahoo.com | |
Hospital General de Occidente | Recruiting |
Guadalajara, Jalisco, Mexico, 045040 | |
Contact: Arturo Rodriguez, MD (5235) 87 90 90 aruro2000@yahoo.com | |
Mexico, Nuevo León | |
Hospital Universitario de Nuevo León | Not yet recruiting |
Monterrey, Nuevo León, Mexico, 64460 | |
Contact: Lauro G Gomez, MD.Uro-Andro (52 55 818) 20 44 44 laurogomez@hotmail.com |
Principal Investigator: | Jorge Jaspersen, MD | H Santa Fe |
Study ID Numbers: | 2006/1084 |
Study First Received: | November 5, 2007 |
Last Updated: | November 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00555087 |
Health Authority: | Mexico: Ethics Committee |
Erectile dysfunction Hypogonadotrophic males |
Sexual Dysfunctions, Psychological Testosterone Vardenafil Sexual Dysfunction, Physiological Mental Disorders |
Methyltestosterone Genital Diseases, Male Erectile Dysfunction Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Sexual and Gender Disorders Pharmacologic Actions Androgens |