Status:
COMPLETED
Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women
Lead Sponsor:
Mayo Clinic
Conditions:
Healthy
Eligibility:
FEMALE
50-80 years
Phase:
PHASE1
Brief Summary
Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal women. Preliminary data are sought to estimate statistical power for more detailed studies of this hypothesis...
Detailed Description
The systemic availability and orderly secretion patterns of GH and sex steroids decline in healthy aging men and women. The combined changes have substantial clinical implications to aging-related phy...
Eligibility Criteria
Inclusion
- women ages 50 to 80
- postmenopausal as defined by: any combination of the following
- Hormonally postmenopausal for 1 year
- Lh greater than 15 IU/L, FSH greater than 30 IU/L
- Total hysterectomy with oophorectomy greater than one year
- Hysterectomy with ovaries preserved with hormone levels: Lh \> 15 IU/L, FSH \> 30 IU/L
- Following laboratory results with normal range, unless PI approves out of range values.
- BMI 18 to 35
Exclusion
- structural hypothalamo-pituitary-gonadal disease
- endocrinopathy (diseases involving the following organs pituitary, thyroid, adrenals, ovaries, testes and pancreas), other than primary thyroid failure receiving replacement
- recent (within 2 weeks) estrogen, progestin, anabolic steroid or glucocorticoid use
- clinically significant ECG abnormality as determined by study team physicians
- obstructive uropathy
- history of a stroke
- history of MI or angina
- acute or chronic systemic disease
- recent transmeridian travel (traversing more than 3 time zones within 7 days of admission)
- current night shift work
- concurrent use of neuropsychiatric medications
- alcohol or drug abuse, current and within 2 years
- history of depression, psychosis, or mania
- weight gain or loss (2 kg or more in 3 weeks)
- BMI \> 35 kg/m2
- anemia, hemoglobin less than 12.5 g/dl
- abnormal hepatorenal function, creatinine outside normal range, ALT greater than two times normal range
- biochemical and chemistry lab results out of physician acceptable range
- history of deep-vein thrombophlebitis
- history of Congestive Heart Failure, cardiac arrhythmias, and medications used to treat cardiac arrhythmias
- known allergy to estradiol valerate, castor oil or sesame oil
- history of smoking within the last 2 years
- untreated gall bladder disease
- lack of voluntary, written informed consent
- history of carcinoma excluding localized basal cell or squamous cell, including women with known, suspected or history of breast cancer
- not clinically postmenopausal
- women with allergies to nuts will not be enrolled in the study.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02272647
Start Date
December 1 2014
End Date
February 1 2018
Last Update
March 22 2018
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905