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Sex Hormones and Orthostatic Tolerance

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01153581
First received: June 28, 2010
Last updated: December 1, 2016
Last verified: December 2016
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Orthostatic Intolerance
Interventions: Drug: Ganirelix acetate
Drug: 17β-Oestradiol
Drug: Progesterone

  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
No text entered.

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
Women With and Without Orthostatic Intolerance

Estrogen and Progesterone

17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills

17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day


Participant Flow:   Overall Study
    Women With and Without Orthostatic Intolerance
STARTED   109 
COMPLETED   109 
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.
No text entered.

Reporting Groups
  Description
Women

Estrogen and Progesterone

17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills

17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day


Baseline Measures
   Women 
Overall Participants Analyzed 
[Units: Participants]
 109 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      109 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 22  (1) 
Gender 
[Units: Participants]
Count of Participants
 
Female      109 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      15  13.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      29  26.6% 
White      48  44.0% 
More than one race      3   2.8% 
Unknown or Not Reported      14  12.8% 
Region of Enrollment 
[Units: Participants]
 
United States   109 


  Outcome Measures
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1.  Primary:   Orthostatic Tolerance   [ Time Frame: 2 months ]

2.  Primary:   Baroreceptor Function   [ Time Frame: 2 months ]

3.  Primary:   Skin Microvascular Responses   [ Time Frame: 2 months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nina Stachenfeld
Organization: Yale School of Medicine
phone: 203-562-9901 ext 219
e-mail: nina.stachenfeld@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01153581     History of Changes
Other Study ID Numbers: 0512000875a
2R01HL071159-04 ( US NIH Grant/Contract Award Number )
Study First Received: June 28, 2010
Results First Received: July 8, 2014
Last Updated: December 1, 2016