Status:
COMPLETED
Postmenopausal Women Estrogen and Progesterone Infusion
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Postmenopause
Aging
Eligibility:
FEMALE
45-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to study the effects of aging, estrogen and progesterone on the brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands in the brain) r...
Detailed Description
The transition to menopause is characterized by a decline in the numbers of functional ovarian follicles followed by a decrease in levels of inhibin A and B and complex changes in estradiol, which inc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- postmenopausal women young (age 45-55) or old (age 70-80) History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) Normal TSH, PRL and CBC, and Factor V activity Normal BUN and Creatinine (\< 2 times the upper limit of normal) BMI between 18 to 30 kg/m2 An increased FSH measured at the screening visit will be consistent with menopause. If the initial determination is low, a repeat sample may be drawn.
- Exclusion criteria:
- Hormonal medication or herbal supplements and/or over the counter menopause therapy in the 2 months prior to study Any absolute contraindications to the use of physiologic replacement doses of estrogen and/or progesterone History of coronary artery disease Medications thought to act centrally on the GnRH pulse generator History of breast cancer or blood clots Smoking more than 10 cigarettes/day Prior history of allergic reaction to any dyes used with x-rays or scans and/ or any other contraindications to PET scans No metal implants, pacemakers, aneurysm clips, implanted hearing aids and/or any other contraindications to MRI scan
Exclusion
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00455741
Start Date
November 1 2000
End Date
August 22 2015
Last Update
May 18 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114