Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

This study has been terminated.
(Enrollment too low and PI has left the University of Missouri)
Sponsor:
Information provided by (Responsible Party):
Paul Fadel, PhD, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01633814
First received: June 25, 2012
Last updated: August 11, 2016
Last verified: August 2016
  Purpose
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 alone, transdermal estrogen plus progesterone, progesterone alone and placebo.

Condition Intervention
Physiological Processes [G07.700]
Aging [G07.700.320.124]
Exercise [G11.427.590.530.698.277]
Drug: Transdermal estradiol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Influence of Hormone Replacement on Neural Cardiovascular Control in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: September 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal estradiol
Transdermal estradiol, delivery rate 100 µg day-1
Drug: Transdermal estradiol
transdermal estradiol, delivery rate 100 µg day-1
Placebo Comparator: Placebo
placebo patch.
Drug: Placebo
placebo patch.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633814

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Paul J Fadel, PhD University of Missouri-Columbia
  More Information

Responsible Party: Paul Fadel, PhD, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01633814     History of Changes
Other Study ID Numbers: 1133919 
Study First Received: June 25, 2012
Last Updated: August 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hormones
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 30, 2016