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Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633814
Recruitment Status : Terminated (PI left institution prior to completion of study. Data unavailable..)
First Posted : July 4, 2012
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
Older women have an exaggerated increase in blood pressure during exercise. However, the reasons for this are unclear. It is important to investigate this phenomenon because a greater blood pressure response to exercise has been associated with an increased risk of stroke and mortality in otherwise healthy individuals. A unique aspect of aging in women is the profound change in hormone levels (i.e. estrogen and progesterone) associated with menopause. The influence of changes in estrogen and progesterone levels on the cardiovascular responses to exercise is poorly understood. However, it has been suggested that these hormones might change the responsiveness of the cardiovascular system. Possible mechanisms that could account for these changes are the arterial baroreflex and feedback from the exercising muscle (known as the exercise pressor reflex), both of which are known to powerfully modulate blood pressure during exercise. However, to date, few human studies have thoroughly examined the influence of changes in hormone levels on baroreflex function during exercise or the exercise pressor reflex in older women. As such, the purpose of this research project is to assess baroreflex function and the exercise pressor reflex in older women after transdermal estrogen and placebo.

Condition or disease Intervention/treatment Phase
Menopause Aging Blood Pressure Drug: Transdermal estradiol Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Influence of Hormone Replacement on Neural Cardiovascular Control in Postmenopausal Women
Actual Study Start Date : September 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Transdermal estradiol
Transdermal estradiol, delivery rate 100 µg day-1
Drug: Transdermal estradiol
transdermal estradiol, delivery rate 100 µg day-1
Other Name: Elestrin

Placebo Comparator: Placebo
placebo patch.
Drug: Placebo
placebo patch.

Primary Outcome Measures :
  1. Change in Carotid Baroreflex Sensitivity (Bpm/mmHg) [ Time Frame: Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo. ]
    Carotid baroreflex sensitivity will be measured using the application of neck pressure and neck suction. Briefly, a variable neck pressure collar will be placed around the anterior two thirds of the neck to change carotid sinus transmural pressure.

  2. Change in Exercise Pressor Reflex Responsiveness (Mean Blood Pressure Response (mmHg) and Muscle Sympathetic Nerve Activity Response (Burst Frequency) During Post Handgrip Ischemia.) [ Time Frame: Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo. ]
    To estimate exercise pressor reflex responsiveness changes in blood pressure and muscle sympathetic nerve activity from rest to during a period of post handgrip ischemia will be used.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • We plan to study female subjects of all ethnic backgrounds ranging in age from 18 to 80 years. Only healthy, normotensive individuals not taking medications will be included in this study.
  • All postmenopausal women will be at least 4 years post menopause to avoid the potential for perimenopausal interference with study results

Exclusion Criteria:

  • Active cardiopulmonary disease
  • Hypertension
  • Diabetes
  • Chronic Obstructive Pulmonary Disease with concurrent daily use of inhalers.
  • Known liver disease
  • Peripheral neuropathy
  • Chronic Kidney disease
  • Pregnant women
  • Any of the following contraindications to estrogen usage will cause exclusion:
  • Personal or 1st degree relative (mother, sister, daughter) history of breast, ovarian, or uterine cancer
  • Vaginal bleeding;
  • Current thrombophlebitis or venous thromboembolic disorders including deep vein thrombosis or pulmonary embolus;
  • Arterial thromboembolic disease such as stroke or myocardial infarction
  • Migraine headaches
  • Any previous intolerance to estrogen supplementation.
  • Women who have smoked during the one-year period prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633814

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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
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Principal Investigator: Paul J Fadel, PhD University of Missouri-Columbia
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Responsible Party: University of Missouri-Columbia Identifier: NCT01633814    
Other Study ID Numbers: 1133919
First Posted: July 4, 2012    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Missouri-Columbia:
Physiological Processes
Hormone replacement therapy
Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs