Status:
COMPLETED
Estradiol-Receptor Blockade in Older Men and Women
Lead Sponsor:
Mayo Clinic
Conditions:
Normal Healthy Volunteers
Eligibility:
All Genders
50-80 years
Phase:
PHASE1
Brief Summary
Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation...
Detailed Description
Systemic concentrations of Te, E2, GH, IGF-I and insulin growth factor binding protein 3 (IGFBP-3) decline in healthy aging men and women. Relative sex-steroid deprivation accentuates GH and IGF-I dep...
Eligibility Criteria
Inclusion
- Inclusion:
- 40 healthy women and men (ages 50 to 80 y); women will be post-menopausal (clinically defined by E2 \< 50 pg/mL, FSH \> 30Iu/L)
- BMI 18-35 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, viz potassium \<3.5 mEq/L, magnesium \<1.5 mEq/L, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver functions tests twice upper limit of normal, anemia (hemoglobin must meet Blood Bank requirements - Hgb ≥ 12.5 g/dL)
- drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- acute or chronic organ-system disease, including renal failure (creatinine \> 1.5 mg/dL)
- endocrinopathy, other than primary thyroidal failure receiving replacement
- 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 toremifene
- unwillingness to provide written informed consent.
- PSA \> 4.0 ng/mL in men
- History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy, or breast cancer),
- Other 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, congenital QT prolongation, and medications used to treat cardiac arrhythmias or other strong CYP3A4 inhibitors.
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02271282
Start Date
December 1 2014
End Date
May 1 2016
Last Update
September 14 2016
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905