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Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

This study has been terminated.
(PI left institution prior to completion of study. Data unavailable..)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633814
First Posted: July 4, 2012
Last Update Posted: August 10, 2017
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.
Information provided by (Responsible Party):
University of Missouri-Columbia
Results First Submitted: May 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Conditions: Menopause
Aging
Blood Pressure
Interventions: Drug: Transdermal estradiol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Transdermal Estradiol or Placebo

Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch

Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1


Participant Flow:   Overall Study
    Transdermal Estradiol or Placebo
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Transdermal Estradiol or Placebo

Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch

Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1


Baseline Measures
   Transdermal Estradiol or Placebo 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
50 - 80 years of age   
Participants Analyzed 
[Units: Participants]
 0 
50 - 80 years of age   0 
[1] 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.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
  
[1] 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.
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: University of Missouri
phone: 573-884-5220
e-mail: fadelp@health.missouri.edu



Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01633814     History of Changes
Other Study ID Numbers: 1133919
First Submitted: June 25, 2012
First Posted: July 4, 2012
Results First Submitted: May 1, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 10, 2017