Sponsor study identifier
Secondary identifiers
NIH
interventional
20
1 country
1
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
August 22, 2015
Actual (reported)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) respond to estrogen. The pituitary gland is controlled by the hypothalamus. The hypothalamus secretes GnRH (Gonadotropin-Releasing Hormone) that signals the pituitary to secrete the reproductive hormones, LH (Luteinizing Hormone) and FSH (Follicle Stimulating Hormone). These hormones act on the ovaries and signal the ovaries to produce estrogen and progesterone. Estrogen in the bloodstream then acts on the brain to modulate this system with changes in LH and FSH. Early changes associated with low levels of estrogen are inhibitory (estrogen negative feedback) while higher levels of estrogen (such as those present when a follicle in the ovary is ready to ovulate) stimulate LH to cause ovulation (positive feedback). This study will determine: 1) hypothalamic and pituitary levels of glucose uptake (as a measure of brain metabolic activity) at baseline and in association with estrogen negative feedback on LH (24 hr) and estrogen positive feedback on LH (72 hr); and 2) the effect of aging on estrogen feedback on LH, assessing negative feedback (nadir \~ 24 hr) and positive feedback (peak between 72 and 96 hr).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 22, 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
February 2007
Actual (reported)April 2, 2007
Actual (reported)April 4, 2007
Actual (reported)August 22, 2015
Actual (reported)May 18, 2018
Actual (reported)Effect of Aging on Estrogen Negative Feedback on LH
Difference between baseline LH (average of 3 samples drawn 15 min apart) and nadir LH based on a 3-point moving average of blood samples drawn every 4 hours over 120 hr, expressed as a percent of baseline (% baseline).
Baseline at 0 time before infusion, nadir occurred between 8 and 60 hr (mean 24 hr)
Effect of Aging on Estrogen Positive Feedback on LH
LH area under the curve in response to estrogen positive feedback. Area under the curve was calculated from blood samples drawn every 4 hours from the onset of positive feedback until the end of the study (120 min). The onset of positive feedback is defined as the time when LH first exceeds mean + 2SD of the previous three time points and shows a sustained rise.
Onset of surge (average of 61 hr from beginnning of infusion until the end of the study (120 hr)
18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Negative Feedback
Baseline vs 24 hr after the onset of steroid infusion
18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Negative Feedback
0 vs 24 hr
18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Positive Feedback
24 hr vs 72 hr
18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Positive Feedback
24 vs 72 hr
Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women.
Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women..
Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.
Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Shaw ND, Srouji SS, Histed SN, Hall JE. Differential effects of aging on estrogen negative and positive feedback. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E351-5. doi: 10.1152/ajpendo.00150.2011. Epub 2011 May 10.
Ottowitz WE, Derro D, Dougherty DD, Lindquist MA, Fischman AJ, Hall JE. FDG-PET analysis of amygdalar-cortical network covariance during pre- versus post-menopausal estrogen levels: potential relevance to resting state networks, mood, and cognition. Neuro Endocrinol Lett. 2008 Aug;29(4):467-74.
PET scan data addresses hypothalamic vs pituitary sites of negative and positive estrogen feedback on LH, but there was insufficient power to address the effect of aging on these secondary measures..
Janet E Hall, M.D.
Massachusetts General Hospital
20 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2007
First Posted
April 4, 2007
Study Start
November 2000
Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism
Contact the study team to confirm eligibility.
Ottowitz WE, Dougherty DD, Fischman AJ, Hall JE. [18F]2-fluoro-2-deoxy-D-glucose positron emission tomography demonstration of estrogen negative and positive feedback on luteinizing hormone secretion in women. J Clin Endocrinol Metab. 2008 Aug;93(8):3208-14. doi: 10.1210/jc.2008-0203. Epub 2008 Jun 3.
Ottowitz WE, Siedlecki KL, Lindquist MA, Dougherty DD, Fischman AJ, Hall JE. Evaluation of prefrontal-hippocampal effective connectivity following 24 hours of estrogen infusion: an FDG-PET study. Psychoneuroendocrinology. 2008 Nov;33(10):1419-25. doi: 10.1016/j.psyneuen.2008.09.013. Epub 2008 Oct 31.
This date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
August 22, 2015
Actual (reported)Last Updated
May 18, 2018
Results First Posted
May 18, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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