Impact of Estradiol Addback

  • Study type:

    Interventional What is this?

    Describes 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 phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 13-000047
  • NCT ID:

    NCT01862835
  • Sponsor Protocol Number:

    13-000047

About this study

Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Johannes Veldhuis, M.D.

Open for enrollment

Jean Wigham R.N.

(507)293-1188

Wigham.Jean@mayo.edu