Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Hormones; Medroxyprogesterone; Medroxyprogesterone Acetate; Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.