Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate (Nebidolocal)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00555087|
Recruitment Status : Unknown
Verified November 2007 by Hospital Santa Fe.
Recruitment status was: Recruiting
First Posted : November 7, 2007
Last Update Posted : November 7, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Hypogonadotrophic Males||Drug: Testosterone Undecanoate and/or PDE-5||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||January 2008|
Experimental: A= Nebido
It is and intervention study with 1 arm
Drug: Testosterone Undecanoate and/or PDE-5
Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
- Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment [ Time Frame: 42 weeks ]
- and/or an affirmative response to the GAQ will be considered for the analysis [ Time Frame: 10 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555087
|Contact: Jorge G Jaspersen, MD-Urology||(5255) 55 64 53 email@example.com|
|Contact: Lauro G Gomez, MD||(5255) 818 2204 firstname.lastname@example.org|
|Hospital Santa Fe||Not yet recruiting|
|Mexico city, D.f., Mexico, 06700|
|Contact: Jorge G Jaspersen, MD-Urology (5255) 55 64 53 70 email@example.com|
|Hospital General de Occidente||Recruiting|
|Guadalajara, Jalisco, Mexico, 045040|
|Contact: Arturo Rodriguez, MD (5235) 87 90 90 firstname.lastname@example.org|
|Hospital General de Occidente||Not yet recruiting|
|Guadalajara, Jalisco, Mexico, 44690|
|Contact: Arturo R Rodriguez, MD-Urology (5255) 333 5879 090 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Jorge Jaspersen, MD||H Santa Fe|