Erectile Dysfunction | Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate
Erectile Dysfunction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Testosterone Undecanoate and/or PDE-5Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
A= NebidoIt is and intervention study with 1 arm
Start Date: May 2007
Completed Date: January 2008
Phase: Phase 4
Primary Outcome: Score higher than or equal to 21 of the erectile dysfunction domain of the IIEF, or response to treatment
Study sponsors, principal investigator, and references
Principal Investigator: Jorge Jaspersen, MD
Lead Sponsor: Hospital Santa Fe