Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

NCT01633814 | Terminated Results DMC

• 1 other identifier: 1133919
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Aging; Blood Pressure

Keywords

Physiological Processes; Exercise; Hormone replacement therapy

Outcome Measures

Primary Outcomes (2)

• Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)

  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.

  Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.

• Change in Exercise Pressor Reflex Responsiveness (Mean Blood Pressure Response (mmHg) and Muscle Sympathetic Nerve Activity Response (Burst Frequency) During Post Handgrip Ischemia.)

  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.

  Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.

Study Arms (2)

Transdermal estradiol

EXPERIMENTAL

Transdermal estradiol, delivery rate 100 µg day-1

Drug: Transdermal estradiol

Placebo

PLACEBO COMPARATOR

placebo patch.

Drug: Placebo

Interventions

Transdermal estradiol DRUG

transdermal estradiol, delivery rate 100 µg day-1

Also known as: Elestrin

Transdermal estradiol

Placebo DRUG

placebo patch.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Total enrollment was 4 women. Study was terminated prematurely early due to poor enrollment and the fact that the PI was moving to another institution. No data was analyzed.

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Missouri

fadelp@health.missouri.edu

573-884-5220

Study Officials

• Paul J Fadel, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 4, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 10, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)