The Effects of Aging and Estrogen on the Pituitary

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to study the effects of aging and estrogen on the brain. Specifically, this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute on Aging (NIA)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; LHRH, N-Ac-2-Nal(1)-4-Cl-Phe(2)-3-Pal(3)-Arg(5)-Glu(6)-AlaNH2(10)-; Polyestradiol phosphate; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• 45-55 or 70-80 years old

• History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) and a FSH level >26 IU/L

• On no hormonal medication or herbal supplements and/or over the counter menopause therapy for a minimum of 2 months prior to study

• Normal thyroid stimulating hormone, prolactin, factor V Leiden, and complete blood count - Normal blood urea nitrogen and creatinine (< 2 times the upper limit of normal)

• basal metabolic index ≤ 30

• Non-smokers or smoke less than 10 cigarettes/day

Exclusion Criteria:

• Absolute contraindications to the use of physiologic replacement doses of estrogen, including a negative screening mammogram within the past 24 months

• History of coronary artery disease

• On medications thought to act centrally on the GnRH pulse generator

• Past history of hypersensitivity or allergy to narcotics, vancomycin, muscle relaxants, aspirin, and/or anaphylactic reaction(s) to other drugs

• Prior history of breast cancer and/or blood clots