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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Hospital Santa Fe.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Hospital Santa Fe
ClinicalTrials.gov Identifier:
NCT00555087
First received: November 5, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Erectile Dysfunction
Hypogonadotrophic Males
Drug: Testosterone Undecanoate and/or PDE-5
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.

Resource links provided by NLM:


Further study details as provided by Hospital Santa Fe:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2007
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
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
Other Names:
  • Nebido
  • Levitra

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555087

Contacts
Contact: Jorge G Jaspersen, MD-Urology (5255) 55 64 53 70 jaspersen@prodigy.net.mx
Contact: Lauro G Gomez, MD (5255) 818 2204 444 laurogomez@hotmail.com

Locations
Mexico
Hospital Santa Fe Not yet recruiting
Mexico city, D.f., Mexico, 06700
Contact: Jorge G Jaspersen, MD-Urology    (5255) 55 64 53 70    jaspersen@prodigy.net.mx   
Hospital General de Occidente Not yet recruiting
Guadalajara, Jalisco, Mexico, 44690
Contact: Arturo R Rodriguez, MD-Urology    (5255) 333 5879 090    aruro2000@yahoo.com   
Hospital General de Occidente Recruiting
Guadalajara, Jalisco, Mexico, 045040
Contact: Arturo Rodriguez, MD    (5235) 87 90 90    aruro2000@yahoo.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    laurogomez@hotmail.com   
Sponsors and Collaborators
Hospital Santa Fe
Bayer
Investigators
Principal Investigator: Jorge Jaspersen, MD H Santa Fe
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00555087     History of Changes
Other Study ID Numbers: 2006/1084
Study First Received: November 5, 2007
Last Updated: November 5, 2007
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Santa Fe:
Erectile dysfunction
Hypogonadotrophic males

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014