Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Arkansas |
---|---|
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00575029 |
Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.
Although only approved to combat weight loss associated with AIDS and cancer, MA is frequently prescribed for long periods of time to prevent or reverse weight loss in nursing home residents and in elderly patients with serious illnesses in the community. Little data is available to support this practice. Among its many properties, MA acts as a partial glucocorticoid agonist, and long term and short term use of MA may results in adrenal suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course of resumption of normal adrenal function after discontinuation of MA is completely unknown. As a consequence, it is unclear whether MA can be given safely for short periods of time or whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a substantial risk of adrenal crisis after an illness, requires a clear understanding of these issues. To address these concerns, we will evaluate adrenal function before, during, and after MA administration in healthy volunteers between the ages of 60 and 85 years.
Condition | Intervention |
---|---|
Adrenal Function |
Drug: megestrol acetate |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate |
Estimated Enrollment: | 15 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
---|---|
a: Experimental
all subjects
|
Drug: megestrol acetate
600 mg by mouth daily
|
Ages Eligible for Study: | 65 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded if they have a history of (H/O):
Contact: donald l bodenner, md | 501-526-5705 | bodennerdonald@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
little rock, Arkansas, United States, 72205 | |
Principal Investigator: donald l bodenner, md |
Principal Investigator: | donald l bodenner | associate professor |
Responsible Party: | university of arkansas for medical sciences ( Donald Bodenner MD ) |
Study ID Numbers: | 26835 |
Study First Received: | December 13, 2007 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00575029 |
Health Authority: | United States: Institutional Review Board |
megestrol acetate adrenal insufficiency adrenal suppression |
Adrenal Insufficiency Epinephrine Hypoadrenalism |
Megestrol Megestrol Acetate Adrenal gland hypofunction |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants |
Reproductive Control Agents Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |