Status:
COMPLETED
Impact of Estradiol Addback
Lead Sponsor:
Mayo Clinic
Conditions:
Normal Healthy Volunteers
Eligibility:
MALE
60-80 years
Phase:
PHASE1
Brief Summary
Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.
Detailed Description
Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in healthy aging men. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates G...
Eligibility Criteria
Inclusion
- Inclusion:
- 60 healthy men (ages 60 to 80 y);
- BMI 18-30 kg/m2
- Community dwelling; and voluntarily consenting
- Exclusion:
- Recent use of psychotropic or neuroactive drugs (within five biological half-live);
- Obesity (outside weight range above);
- Laboratory test results not deemed physician acceptable, cholesterol \>250, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver functions tests twice upper limit of normal, electrolyte abnormality, anemia; hemoglobin \<12.0 gm/dL
- Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- Acute or chronic organ-system disease;
- Endocrinopathy, other than primary thyroidal failure receiving replacement; untreated osteoporosis
- Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
- Acute weight change (loss or gain of \> 2 kg in 6 weeks);
- Allergy to peanut oil (used in some injectable Te preparations)
- Unwillingness to provide written informed consent.
- PSA \> 4.0 ng/mL
- History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy.
- History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence.
- History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
- History of CHF, cardiac arrhythmias, congential QT prolongation, and medications used to treat cardiac arrhythmias
- Gynecomastia \> 2 cm, untreated
- Untreated gallbladder disease
- History of smoking greater than one ppd.
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01862835
Start Date
May 1 2013
End Date
December 30 2018
Last Update
June 7 2019
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905