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The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration
This study is currently recruiting participants.
Verified by Yale University, February 2009
First Received: January 2, 2008   Last Updated: February 13, 2009   History of Changes
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00589134
  Purpose

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 will perform endurance exercise in the heat under three hormonal conditions: 1) during Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+ progesterone. During exercise, fluid will be replaced with either water or a carbohydrate-electrolyte beverage (random assignment).


Condition Intervention
Exercise Induced Hyponatremia
Dietary Supplement: Gatorade Endurance Formula
Other: ganirelix acetate

MedlinePlus related topics: Drinking Water Exercise and Physical Fitness
Drug Information available for: Estradiol Progesterone Vasopressins Arginine Argipressin Ganirelix Ganirelix acetate Arginine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration

Further study details as provided by Yale University:

Primary Outcome Measures:
  • osmotic regulation of AVP [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • temperature responses [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589134

Contacts
Contact: Nina Stachenfeld, PhD 203-562-9901 ext 219 nstach@jbpierce.porg
Contact: Cheryl Leone, MA 203-562-9901 ext 266 cleone@jbpierce.org

Locations
United States, Connecticut
John B. Pierce Laboratory Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Nina Stachenfeld, PhD            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Nina Stachenfeld, PhD John B. Pierce Laboratory
  More Information

No publications provided

Responsible Party: Gatorade Sports Science Institute ( Craig Horswill )
Study ID Numbers: 188, 0508000538
Study First Received: January 2, 2008
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00589134     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Progesterone
Hyponatremia
Hormone Antagonists
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Estradiol 17 beta-cypionate
Hormones
Hemostatics
Estradiol
Arginine Vasopressin
Ganirelix
Progestins
Estradiol 3-benzoate
Vasoconstrictor Agents
Vasopressins
Water-Electrolyte Imbalance
Polyestradiol phosphate
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Coagulants
Progesterone
Hyponatremia
Hormone Antagonists
Hematologic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Hormones
Hemostatics
Pharmacologic Actions
Arginine Vasopressin
Ganirelix
Natriuretic Agents
Progestins
Therapeutic Uses
Vasopressins
Vasoconstrictor Agents
Water-Electrolyte Imbalance
Antidiuretic Agents

ClinicalTrials.gov processed this record on May 07, 2009