Effect of Testosterone in Men With Erectile Dysfunction (TED)
Erectile Dysfunction, Testosterone Deficiency, Diabetes
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring testosterone, erectile dysfunction, sildenafil
Eligibility Criteria
Inclusion Criteria:
- Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and 25 (mild to moderate ED)
- Neutral or extremely dissatisfied with one's sex life
- Presence of androgen deficiency defined as serum total testosterone level less than 300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by equilibrium dialysis) less than 50 pg/ml.
- Able to understand the nature of the study and provide written, informed consent
Exclusion Criteria:
- Contraindication for use of testosterone, e.g., history of prostate or breast cancer
- benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater
- erythrocytosis (hematocrit >50% at baseline)
- untreated, severe sleep apnea
- serum PSA levels >4 ug/L will be excluded unless they have had a urologic evaluation in the past three months to exclude prostate cancer.
- Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease taking long-acting or short-acting nitrate drugs on a regular basis.
- Symptomatic postural hypotension
- Congestive heart failure with class III or IV symptoms
- History of myocardial infarction or stroke within the past six months
- Primary diagnosis of another sexual disorder such as premature ejaculation
- AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of normal, creatinine greater than 2 mg/dL.
- Currently taking testosterone or oral androgen precursors; unless willing to discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch or gel) or 6 weeks (if injectable testosterone) before the initial screen visit.
- Currently taking medications that affect androgen metabolism, action, or clearance (dilantin, phenobarbital, aldactone, flutamide, finasteride).
- Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline hemoglobin A1C is less than 8.5%.
- Structural abnormalities of the penis, including Peyronie's disease, will be excluded.
- Men who are taking medications for erectile dysfunction, including sildenafil, must stop using these medications for at least 4 weeks before starting Visit 2.
- DSM-IV criteria for an Axis I psychiatric disorder within the past year, including depression; use of psychotropic medication for at least six months, or dementia is also an exclusion.
Sites / Locations
- Boston University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active Testosterone Gel
Placebo Gel
Active Testosterone Gel and on demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.
Placebo Gel and on demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.