Effect of Testosterone in Men With Erectile Dysfunction

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this placebo-controlled study is to determine if testosterone replacement therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R) treatment in men who have erectile dysfunction (ED) and low testosterone levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Citric Acid; Methyltestosterone; Phosphodiesterase Inhibitors; Sildenafil Citrate; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.