Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02272647

Run by

Mayo Clinic

People needed

47

Starts

2014-12-01

Expected to finish

2018-02-01

Last updated by the study team

2018-03-22

Who can join

Age: 50 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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