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NCT00589134 · ClinicalTrials.gov registry record · NA
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
A NA study of Exercise Induced Hyponatremia, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00589134: Completed NA study of Exercise Induced Hyponatremia, sponsored by Yale University.
NCT00589134 is a NA study of Exercise Induced Hyponatremia that has completed, run by Yale University. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589134, a NA study of Exercise Induced Hyponatremia, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration) and this risk has been attributed to their lower body weight and size, excess water ingestion and longer racing times relative to men. While these factors contribute to the greater incidence of hyponatremia in women, it is likely that their greater levels of estradiol in plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More importantly, estradiol may also leave women more susceptible to the extreme consequences of hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most important hormone controlling water retention in the kidney. Earlier studies in our laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP release during exercise. The purpose of these studies is to test the hypotheses that in women with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release, leading to greater fluid retention, lower blood sodium concentration during endurance exercise in the heat. However, we further hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on the regulation of thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance exercise in the heat. In women without a history of hyponatremia, we expect that estradiol administration will lower the thresholds for thirst and AVP release, but will not increase fluid retention or reduce blood sodium concentration during endurance exercise in the heat. We hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or serum sodium concentration during endurance exercise in the heat. To test these hypotheses, women
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Gatorade Endurance Formula
- OTHER ganirelix acetate
Study Locations (1)
Connecticut
- John B. Pierce Laboratory - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-01 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT00589134 record still lists
NCT00589134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Exercise Induced Hyponatremia appearing as the primary indexed condition, and to 2 interventions - of which Gatorade Endurance Formula is the first listed.
NCT00589134 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT00589134 about?
NCT00589134 is a clinical study titled "The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration". Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration) and this risk has been attributed to their lower body weight and size, excess water ingestion and longer racing times relative to men. While these factors contribute to the greater incidence of hyponatremia ...
What is the current status of trial NCT00589134?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2006-01. Estimated completion is 2009-12.
What conditions does trial NCT00589134 study?
This clinical trial studies the following conditions: Exercise Induced Hyponatremia.
What interventions are being tested in trial NCT00589134?
The interventions under investigation include: Gatorade Endurance Formula (DIETARY_SUPPLEMENT), ganirelix acetate (OTHER).
Who is sponsoring clinical trial NCT00589134?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00589134 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00589134's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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