Overview
Impact of Estradiol Addback
Status:
Completed
Completed
Trial end date:
2018-12-30
2018-12-30
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Mayo ClinicTreatments:
Anastrozole
Estradiol
Estrogens
Testosterone
Criteria
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.