Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

Erectile Dysfunction Clinical Trial

— Nebidolocal  

Official title:

Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00555087
• Other study ID #: 2006/1084
• Status: Recruiting
• Phase: Phase 4
• First received: November 5, 2007
• Last updated: November 5, 2007
• Start date: May 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2007
• Source: Hospital Santa Fe
• Contact: Jorge G Jaspersen, MD-Urology
• Phone: (5255) 55 64 53 70
• Email: jaspersen[@]prodigy.net.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypogonadotrophic Males

Intervention

Drug:
• Testosterone Undecanoate and/or PDE-5
Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg

Locations

Country	Name	City	State
Mexico	Hospital General de Occidente	Guadalajara	Jalisco
Mexico	Hospital General de Occidente	Guadalajara	Jalisco
Mexico	Hospital Santa Fe	Mexico city	D.f.
Mexico	Hospital Universitario de Nuevo León	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Santa Fe	Bayer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment		42 weeks
Primary	and/or an affirmative response to the GAQ will be considered for the analysis		10 months