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NCT01153581 · ClinicalTrials.gov registry record · Phase 2
Sex Hormones and Orthostatic Tolerance
A Phase 2 study of Orthostatic Intolerance, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT01153581: Completed Phase 2 study of Orthostatic Intolerance, sponsored by Yale University.
NCT01153581 is a Phase 2 study of Orthostatic Intolerance that has completed, run by Yale University. The registered enrollment target is 109 participants, below the 139-participant average among 5 other Orthostatic Intolerance trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01153581, a Phase 2 study of Orthostatic Intolerance, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Ganirelix acetate
- DRUG 17β-Oestradiol
Study Locations (1)
Connecticut
- John B. Pierce Laboratory - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01153581 record still lists
NCT01153581 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 139-participant average among 5 other Orthostatic Intolerance trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Orthostatic Intolerance appearing as the primary indexed condition, and to 3 interventions - of which Progesterone is the first listed.
NCT01153581 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01153581 about?
NCT01153581 is a clinical study titled "Sex Hormones and Orthostatic Tolerance". This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.
What is the current status of trial NCT01153581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2006-02. Estimated completion is 2013-05.
What conditions does trial NCT01153581 study?
This clinical trial studies the following conditions: Orthostatic Intolerance.
What interventions are being tested in trial NCT01153581?
The interventions under investigation include: Progesterone (DRUG), Ganirelix acetate (DRUG), 17β-Oestradiol (DRUG).
Who is sponsoring clinical trial NCT01153581?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01153581 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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