Status:
UNKNOWN
The Effects of Aging and Estrogen on the Pituitary
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Healthy
Eligibility:
FEMALE
45-80 years
Phase:
PHASE2
PHASE3
Brief 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 hor...
Detailed Description
Although it is clear that loss of ovarian function plays a major role in the menopause in women, there is evidence from animal studies that primary age-related hypothalamic and pituitary changes may a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00386022
Start Date
January 1 2002
End Date
January 1 2018
Last Update
April 13 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114