Effect of Testosterone in Men With Erectile Dysfunction
Condition: Erectile Dysfunction; Testosterone Deficiency; Diabetes
MeSH terms: Erectile Dysfunction
Intervention: Sildenafil citrate (open label); Testosterone gel; Placebo gel
Intervention description: 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.; Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.; 3 tubes of placebo gel equivalent to the amount of the testosterone gel will be applied during the placebo-controlled testosterone gel intervention for 16 weeks..
Intervention MeSH terms: Sildenafil Citrate; Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: Male
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: testosterone; erectile dysfunction; sildenafil

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.
    

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.