Sex Hormones and Orthostatic Tolerance
|ClinicalTrials.gov Identifier: NCT01153581|
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : January 30, 2017
Last Update Posted : January 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Orthostatic Intolerance||Drug: Ganirelix acetate Drug: 17β-Oestradiol Drug: Progesterone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Sex Hormones and Orthostatic Tolerance|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Experimental: Ganirelix acetate
Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA)
Drug: Ganirelix acetate
Ganirelix acetate: .25 ml/day by subcutaneous injection
Other Name: Antagon
Experimental: 17β-Oestradiol, E2
The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
17 beta estradiol: 0.2 mg/day (patches)
The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.
progesterone, 200 mg day−1 oral
- Orthostatic Tolerance [ Time Frame: 2 months ]We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.
- Baroreceptor Function [ Time Frame: 2 months ]
This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.
Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.
- Skin Microvascular Responses [ Time Frame: 2 months ]Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as "% max." This is measured with a Laser Doppler probes, which measures volts.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153581
|United States, Connecticut|
|John B. Pierce Laboratory|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Nina Stachenfeld, PhD||Yale University|