Phase 4
N=140
Effect of Testosterone in Men With Erectile Dysfunction
Erectile Dysfunction · Testosterone Deficiency · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00512707 ↗Enrolled (actual)
140
Serious AEs
4.3%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) — 19.6; 20.1; 21.3; 21.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sildenafil citrate (open label) (Drug); Testosterone gel (Drug); Placebo gel (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Boston University
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) |
19.6; 20.1; 21.3; 21.3; 22.5; 20.1 | — |
| SECONDARY Change From Baseline in Other Domains of International Index of Erectile Function (IIEF) |
7.0; 7.0; 7.6; 7.8; 7.9; 7.4 | — |
| SECONDARY Change From Baseline in Sexual Encounter Profile (SEP) |
2.8; 3.0; 2.8; 3.0; 3.3; 3.0 | — |
| SECONDARY Change From Baseline in Successful Sexual Intercourse of Sexual Encounter Profile (SEP) |
76; 74; 78; 84; 80; 79 | — |
| SECONDARY Change From Baseline in Men's Sexual Health Questionnaire (MSHQ) |
5.3; 5.9; 6.3; 6.9; 6.9; 7.2 | — |
| SECONDARY Change From Baseline in Quality of Life Specific to Male Erection Difficulties (QOL-MED) |
56; 62; 65; 70; 66; 69 | — |
| SECONDARY Change From Baseline in Marital Interaction Scale of CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) |
0.79; 0.74; 0.86; 0.79; 0.81; 0.79 | — |
| SECONDARY Change From Baseline in Psychological General Well-Being Index Score (PGWBI) |
60; 63; 65; 63; 64; 60 | — |
| SECONDARY Change From Baseline in Derogatis Affects Balance Scale (DABS) |
12.7; 13.1; 13.1; 13.5; 13.2; 12.7 | — |
| SECONDARY Change From Baseline in Positive Affects Ratio (PAR) of Derogatis Affects Balance Scale (DABS) |
0.75; 0.76; 0.76; 0.77; 0.78; 0.76 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00512707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.