Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

Condition(s) targeted: Erectile Dysfunction; Hypogonadotrophic Males

Intervention: Testosterone Undecanoate and/or PDE-5 (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Santa Fe

Official(s) and/or principal investigator(s):
Jorge Jaspersen, MD, Principal Investigator, Affiliation: H Santa Fe

Overall contact:
Jorge G Jaspersen, MD-Urology, Phone: (5255) 55 64 53 70, Email: jaspersen@prodigy.net.mx

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment

and/or an affirmative response to the GAQ will be considered for the analysis

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients older than 18 years old and younger than 70 years.

- To have diagnosis of erectile dysfunction by IIEF. Qualification less than 46 points

and/or GAQ with Answer "NO".

- Patients with Inform consent letter signed.

- Patients without any therapy with other type of testosterone, gonadotrophines and/or

PDE-5 in the previous 4 weeks of their inclusion at the study.

- Diagnosis of hypogonadism according to the criteria:

- Testosterone dosage lower than 12 nmol/L

- Free testosterone shall be below 180 pmol/L o 52 pg/mL

Exclusion Criteria:

- People less than 18 years old and older than 70 years.

- Patients with history of or with known or suspected sleep apnea.

- Patients who participate in other study protocols

- Known or suspected active systemic infection.

- Patients with HIV + and/ or known HTLV+.

- Patients with hyperprolactinemia

- Patients with known or suspected coagulopathies

- Patients with Klinefelter

- Known or suspected psychiatric illness.

- Patients who have received prior therapy with some kind of testosterone in the last 4

months or a PDE-5 inhibitor in the last month.

- Patients with contraindications for the use of PDE-5 inhibitors

- Patients having a diagnosis of erectile dysfunction but with total and/ or free

testosterone levels within the physiological range.

- Patients with APE ≥ 2. 5 ng/ml in younger than 60 years, or > de 3 ng/ml in older

than 60 years.

- Abnormal prostate findings during the digital rectal examination (that is to say,

irregularities, hard consistency when examined).

- Concomitant malignant diseases or history of prostate cancer

Jorge G Jaspersen, MD-Urology, Phone: (5255) 55 64 53 70, Email: jaspersen@prodigy.net.mx

Hospital Santa Fe, Mexico city, D.F. 06700, Mexico; Not yet recruiting
Jorge G Jaspersen, MD-Urology, Phone: (5255) 55 64 53 70, Email: jaspersen@prodigy.net.mx

Hospital General de Occidente, Guadalajara, Jalisco 44690, Mexico; Not yet recruiting
Arturo R Rodriguez, MD-Urology, Phone: (5255) 333 5879 090, Email: aruro2000@yahoo.com

Hospital General de Occidente, Guadalajara, Jalisco 045040, Mexico; Recruiting
Arturo Rodriguez, MD, Phone: (5235) 87 90 90, Email: aruro2000@yahoo.com

Hospital Universitario de Nuevo León, Monterrey, Nuevo León 64460, Mexico; Not yet recruiting
Lauro G Gomez, MD.Uro-Andro, Phone: (52 55 818) 20 44 44, Email: laurogomez@hotmail.com

Starting date: May 2007
Ending date: January 2008
Last updated: November 5, 2007