- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555087
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate (Nebidolocal)
Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jorge G Jaspersen, MD-Urology
- Phone Number: (5255) 55 64 53 70
- Email: jaspersen@prodigy.net.mx
Study Contact Backup
- Name: Lauro G Gomez, MD
- Phone Number: (5255) 818 2204 444
- Email: laurogomez@hotmail.com
Study Locations
-
-
D.f.
-
Mexico city, D.f., Mexico, 06700
- Not yet recruiting
- Hospital Santa Fé
-
Contact:
- Jorge G Jaspersen, MD-Urology
- Phone Number: (5255) 55 64 53 70
- Email: jaspersen@prodigy.net.mx
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Jalisco
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Guadalajara, Jalisco, Mexico, 045040
- Recruiting
- Hospital General de Occidente
-
Contact:
- Arturo Rodriguez, MD
- Phone Number: (5235) 87 90 90
- Email: aruro2000@yahoo.com
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Guadalajara, Jalisco, Mexico, 44690
- Not yet recruiting
- Hospital General de Occidente
-
Contact:
- Arturo R Rodriguez, MD-Urology
- Phone Number: (5255) 333 5879 090
- Email: aruro2000@yahoo.com
-
-
Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Not yet recruiting
- Hospital Universitario de Nuevo León
-
Contact:
- Lauro G Gomez, MD.Uro-Andro
- Phone Number: (52 55 818) 20 44 44
- Email: laurogomez@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A= Nebido
It is and intervention study with 1 arm
|
Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment
Time Frame: 42 weeks
|
42 weeks
|
and/or an affirmative response to the GAQ will be considered for the analysis
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge Jaspersen, MD, H Santa Fe
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Erectile Dysfunction
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 2006/1084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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