Status:
COMPLETED
DHEA Replacement in Adrenalectomized/Hypoadrenal Patients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Aging
Dehydroepiandosterone Replacement
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The role of dehydroepiandosterone (DHEA) and its sulphated ester (DHEAS) \[together known as DHEA(S)\] in humans remains to be fully elucidated. They are the most abundant circulating steroid hormones...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects who have been adrenalectomised or have been hypoadrenal (from whatever cause) for \> 24 months;
- Subjects who have been on a steady glucocorticoid replacement regime for \>12 months;
- Women of child bearing age in whom oestrogen status has been steady for \> 6 months - i.e. either on or off the oral contraceptive pill for that time;
- Subjects on other forms of hormone replacement therapy (e.g. thyroxin) in whom dose has remained the same for \> 6 months.
- Exclusion criteria:
- BMI \>35 Kg/m2;
- Individuals with fasting blood glucose above 120mg/dl;
- A history of sex hormone dependant malignancy;
- A history of liver disease;
- Renal failure;
- Cardiovascular disease (other than hypertension);
- Polycythaemia;
- Pregnancy or breastfeeding;
- Cerebrovascular disorders;
- Neurological disorders;
- PSA levels above the age related reference range;
- Use of drugs known to alter mood within the 6 months prior to enrolment;
- Any drug known to affect hepatic biotransformation;
- Evidence of psychiatric disease or dementia;
- Postmenopausal women who have been on hormone replacement therapy for less than six months.
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00279929
Start Date
July 1 2002
End Date
June 1 2007
Last Update
May 23 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905