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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00382057 |
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Date of registration:
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26/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Testosterone Effects on Men With the Metabolic Syndrome
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Scientific title:
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Effect of Increasing Testosterone Levels on Insulin Sensitivity in Men With the Metabolic Syndrome |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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72 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00382057 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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William F Crowley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Name:
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Frances J Hayes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 50-75 yr
2. Diagnosis of the metabolic syndrome defined by the American Heart
Association/National Heart, Lung, and Blood Institute guidelines as the presence of
three or more of the following:
- Waist circumference > 102 cm
- Serum triglycerides > 150 mg/dL
- HDL cholesterol < 40 mg/dL
- Blood pressure > 130 mm Hg systolic or 85 mm Hg diastolic, or treatment with
anti-hypertensives
- Fasting serum glucose > 100 mg/dL
3. Plasma total testosterone level less than 300 ng/dL (1 SD below the mean for young
healthy men)
4. Stable weight for previous three months (no weight change greater than or equal to
+/-10 lbs)
5. Normal TSH, prolactin and prostate specific antigen (PSA) levels (<2.5 ng/mL)
Exclusion Criteria:
1. New diagnosis of type 2 diabetes as defined by the ADA criteria: fasting glucose
greater than 126 mg/dL or random blood glucose greater than 200 mg/dL on two
occasions, or on oral hypoglycemic agents
2. History of testicular disorders (i.e. cryptorchidism)
3. History of bleeding disorders (i.e. thrombocytopenia) or baseline hemoglobin levels
less than 12g/dL
4. History of prostate cancer
5. History of sleep apnea (subjects will also be excluded if at their baseline
assessment they admit to heavy snoring, restless sleep, and/or excessive daytime
somnolence)
6. Symptoms of urinary outflow obstruction (i.e. benign prostatic hypertrophy)
7. Illicit drug use or heavy alcohol use (>4 drinks/day)
8. Allergic disorders
9. Current medications (must exclude individuals taking the following medications:
Testosterone, Cimetidine, Spironolactone, Ketoconazole, Finasteride, DHEA,
Androstenedione, Oral steroids, GnRH analogs)
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metabolic Syndrome
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Intervention(s)
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Drug: Goserelin
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Drug: Anastrozole
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Drug: Testosterone
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Primary Outcome(s)
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resting metabolic rate
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muscle and body fat distribution
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muscle biopsy analysis
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insulin sensitivity
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VO2 max
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Secondary ID(s)
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5 K23 DK02858-02 6/15/05
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5 K23 DK02858-1526
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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