The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
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ClinicalTrials.gov Identifier: NCT00589134 |
Recruitment Status
:
Completed
First Posted
: January 9, 2008
Last Update Posted
: July 16, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exercise Induced Hyponatremia | Dietary Supplement: Gatorade Endurance Formula Other: ganirelix acetate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
type of beverage
|
Dietary Supplement: Gatorade Endurance Formula
carbohydrate electrolyte beverage
Other: ganirelix acetate
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days.
Other Name: Antagon
|
- osmotic regulation of AVP [ Time Frame: 3 years ]
- temperature responses [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy volunteers (18-35 yrs) with and without previous exercise induced hyponatremia
Exclusion Criteria:
- conditions that would preclude safe exercise or safe use of hormones

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589134
United States, Connecticut | |
John B. Pierce Laboratory | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Nina Stachenfeld, PhD | John B. Pierce Laboratory |
Responsible Party: | Craig Horswill, Gatorade Sports Science Institute |
ClinicalTrials.gov Identifier: | NCT00589134 History of Changes |
Other Study ID Numbers: |
188 0508000538 |
First Posted: | January 9, 2008 Key Record Dates |
Last Update Posted: | July 16, 2010 |
Last Verified: | July 2010 |
Additional relevant MeSH terms:
Diabetes Insipidus Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases Kidney Diseases Urologic Diseases Pituitary Diseases Endocrine System Diseases Estradiol Progesterone Ganirelix Vasopressins |
Arginine Vasopressin Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Progestins Hemostatics Coagulants Vasoconstrictor Agents Antidiuretic Agents Natriuretic Agents Hormone Antagonists |