Trial Outcomes & Findings for Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women (NCT NCT01633814)
NCT ID: NCT01633814
Last Updated: 2017-08-10
Results Overview
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.
TERMINATED
NA
4 participants
Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.
2017-08-10
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Transdermal Estradiol or Placebo
n=4 Participants
Transdermal estradiol, delivery rate 100 µg day-1 or placebo patch
Transdermal estradiol: transdermal estradiol, delivery rate 100 µg day-1
|
|---|---|
|
Age, Customized
50 - 80 years of age
|
0 Participants
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.
|
PRIMARY outcome
Timeframe: Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.Population: Results are not available due to all members of the study having left the institution and not having made results available.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.Population: Results are not available due to all members of the study having left the institution and not having made results available.
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.
Outcome measures
Outcome data not reported
Adverse Events
Transdermal Estradiol or Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place