Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Paul Fadel, PhD, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01633814
First received: June 25, 2012
Last updated: June 25, 2013
Last verified: June 2013
  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: Estradiol plus progesterone
Drug: Oral Progesterone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal estradiol
Transdermal estradiol, delivery rate 100 µg day-1 plus oral placebo.
Drug: Transdermal estradiol
transdermal estradiol, delivery rate 100 µg day-1 plus oral placebo
Experimental: Estradiol plus progesterone
transdermal estradiol 100 µg day-1 plus oral progesterone (provera 5 mg)
Drug: Estradiol plus progesterone
transdermal estradiol 100 µg day-1 plus oral progesterone (provera 5 mg)
Experimental: Oral Progesterone
placebo patch plus oral progesterone (provera 5 mg)
Drug: Oral Progesterone
placebo patch plus oral progesterone (provera 5 mg)
Placebo Comparator: Placebo
placebo patch plus oral placebo.
Drug: Placebo
placebo patch plus oral placebo.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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
  • COPD 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 Recruiting
Columbia, Missouri, United States, 65212
Contact: Charla L Jay, BSN    573-884-5048    jayc@health.missouri.edu   
Contact: Paul J Fadel    573-884-5220    fadelp@health.missouri.edu   
Principal Investigator: Paul J Fadel, PhD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Paul J Fadel, PhD University of Missouri-Columbia
  More Information

No publications provided

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: June 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 29, 2014