Estradiol-Receptor Blockade in Older Men and Women
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-004704
NCT ID: NCT02271282
Sponsor Protocol Number: 14-004704
About this study
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 in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Johannes Veldhuis, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available