Impact of Endogenous E2 on SSI and GH Rebound

Overview

About this study

Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin inhibition of GH release.

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:

  1. 60 healthy post-menopausal women (ages 55 to 80 y);
  2. BMI 18-30 kg/m2
  3. Community dwelling; and voluntarily consenting

Exclusion:

  1. Recent use of psychotropic or neuroactive drugs (within five biological half-lives);
  2. Obesity (outside weight range above);
  3. Laboratory test results not deemed physician acceptable, cholesterol >250, triglycerides > 300, BUN >30 or creatinine > 1.5 mg/dL, liver function tests exceeding twice upper limit of normal, electrolyte abnormality, anemia;
  4. Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
  5. Systemic inflammatory disease;
  6. Endocrinopathy, other than primary thyroidal failure receiving replacement;
  7. Nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of CRU admission);
  8. Acute weight change (loss or gain of > 2 kg in 6 weeks);
  9. Systemic illness
  10. Unwillingness to provide written informed consent.
  11. Allergy to anastrozole or fulvestrant (treatment drugs).
  12. History or suspicion of breast cancer.
  13. History of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence).
  14. History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep-vein thrombophlebitis.
  15. History of CHF, cardiac arrhythmias, congenital QT prolongation, and medications used to treat cardiac arrhythmias.
  16. Pre-menopausal status as determined by screening hormone measurements.

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

Additional contact information

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Phone: 800-664-4542 (toll-free)

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