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Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate (Nebidolocal)

Primary Purpose

Erectile Dysfunction, Hypogonadotrophic Males

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Testosterone Undecanoate and/or PDE-5

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Hypogonadotrophic males

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital Santa Fe
Hospital General de OccidenteRecruiting
Hospital General de Occidente
Hospital Universitario de Nuevo León

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A= Nebido

Arm Description

It is and intervention study with 1 arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00555087

First Posted

November 5, 2007

Last Updated

November 5, 2007

Sponsor

Hospital Santa Fe

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00555087

Brief Title

Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Santa Fe

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction, Hypogonadotrophic Males

Keywords

Erectile dysfunction, Hypogonadotrophic males

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A= Nebido

Arm Type

Experimental

Arm Description

It is and intervention study with 1 arm

Intervention Type

Drug

Intervention Name(s)

Testosterone Undecanoate and/or PDE-5

Other Intervention Name(s)

Nebido, Levitra

Intervention Description

Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg

Primary Outcome Measure Information:

Title

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

Time Frame

42 weeks

Title

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

Time Frame

10 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jorge G Jaspersen, MD-Urology

Phone

(5255) 55 64 53 70

jaspersen@prodigy.net.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Lauro G Gomez, MD

Phone

(5255) 818 2204 444

laurogomez@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Jaspersen, MD

Organizational Affiliation

H Santa Fe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Santa Fe

City

Mexico city

State/Province

D.f.

ZIP/Postal Code

06700

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge G Jaspersen, MD-Urology

Phone

(5255) 55 64 53 70

jaspersen@prodigy.net.mx

Facility Name

Hospital General de Occidente

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

045040

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arturo Rodriguez, MD

Phone

(5235) 87 90 90

aruro2000@yahoo.com

Facility Name

Hospital General de Occidente

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arturo R Rodriguez, MD-Urology

Phone

(5255) 333 5879 090

aruro2000@yahoo.com

Facility Name

Hospital Universitario de Nuevo León

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauro G Gomez, MD.Uro-Andro

Phone

(52 55 818) 20 44 44

laurogomez@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

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