Status:
COMPLETED
Role of Endogenous Estrogen in Growth-Hormone Regulation in Postmenopausal Women
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
AstraZeneca
Conditions:
Healthy
Eligibility:
FEMALE
50-80 years
Phase:
PHASE1
Brief Summary
Participants are being asked to take part in this research study to learn why growth hormone(GH) levels decline when estrogen production falls at the time of menopause. GH is a hormone released from t...
Detailed Description
Hypotheses: Endogenous estrogen concentrations contribute significantly to maintaining postmenopausal growth-hormone (GH) secretion and; (b) systemic vis-à-vis CNS actions of endogenous estrogen diffe...
Eligibility Criteria
Inclusion
- healthy postmenopausal women (ages 50 to 80 y), wherein menopause is defined by the absence of spontaneous menses for 1 y and a serum concentration of FSH \> 30 IU/L and of (ultrasensitive) estradiol \< 20 pg/mL and verified by medical history and screening blood work;
- normal hemoglobin of \>11.0 g/dL in women (a ferritin level will be drawn, and must be normal, if Hgb is 11.0 - 11.5) , Platelets greater than 200 x 109/L, AST 8-48 U/L.
- Subjects (age 50 and above) will have a screening baseline ECG if not on record from the past year.
Exclusion
- exposure to psychotropic or neuroactive drug within five biological half- lives;
- undesirability, disinclination or ill advisability of withholding estrogen supplements (e.g. under treatment for symptomatic hot flushes; primary physician recommendation);
- BMI \< 19 or \> 35
- drug or alcohol abuse; psychosis, depression, mania or anorexia nervosa;
- acute or chronic organ or systemic inflammatory disease;
- endocrinopathy, other than primary thyroidal failure receiving replacement;
- although fulvestrant has no known intrinsic estrogenicity, for safety reasons we include contraindication to short-term estrogen exposure; e.g.,estrogen-sensitive neoplasia, undiagnosed vaginal bleeding, deep-venous thrombosis, stroke or threatened stroke, clinical evidence of atherosclerotic heart disease, including myocardial infarction and/or angina, refractory high blood pressure, severe type IV hyperlipidemia:
- nightshift work or recent transmeridian travel (exceeding 3 time zones within 5 days of admission);
- systemic anticoagulation other than anti platelet therapy (in view of i.m. injections of fulvestrant); history of bleeding diathesis (ie; disseminated coagulation (DIC), clotting factor deficiency
- acute weight change (\> 3 kg in 6 weeks); and/or
- unwillingness to provide written informed consent.
- Platelets less than 200 x 109 /L
- International normalization ratio(INR) (Prothrombin time) greater than 1.6
- Total bilirubin greater than 1.5 x ULRR
- ALT or AST greater than 2.5 xULRR if no demonstrable liver metastases or greater
- History or hypersensitivity to active or inactive excipients of fulvestrant (ie; castor oil or Mannitol).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01186796
Start Date
June 1 2009
End Date
June 1 2013
Last Update
March 27 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905