Overview

Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass).
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute on Aging (NIA)
Treatments:
Dehydroepiandrosterone
Criteria
Inclusion Criteria:

- Healthy women and men

- Age 60 or older

- Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old

Exclusion Criteria:

- Contraindications to DHEA treatment (personal history of breast cancer or other
estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding in
women, history or evidence of prostate cancer or benign prostatic hyperplasia (BPH) in
men)

- Angina

- Resting blood pressure over 180/95

- Chronic infections

- Hypothyroidism

- Depression

- Hormone therapy within the previous 6 months

- Insulin-dependent or poorly controlled diabetes

- Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL)

Prohibited Medications:

- Hormone therapy other than stable regimen of thyroid replacement

- Oral glucocorticoids

- Insulin