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Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate
This study is currently recruiting participants.
Verified by University of Arkansas, December 2007
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00575029
  Purpose

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

Drug Information available for: Megestrol acetate Megestrol Epinephrine Epinephrine bitartrate
U.S. FDA Resources
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

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • degree of adrenal suppression and rapidity of onset [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elderly males and females
  • Age 65-80 years
  • With stable (no history of urgent/ emergent care visits with health care provider/s in the preceding 2 months), medical conditions

Exclusion Criteria:

Subjects will be excluded if they have a history of (H/O):

  • Dementia
  • Adrenal disease
  • Thromboembolism
  • Diabetes mellitus
  • Liver disease
  • Electrolyte abnormalities; or
  • Vaginal bleeding
  • Hypertriglyceridemia
  • CAD with CHF
  • Unstable depression
  • Schizophrenia; and
  • Morbidly obese subjects.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575029

Contacts
Contact: donald l bodenner, md 501-526-5705 bodennerdonald@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
little rock, Arkansas, United States, 72205
Principal Investigator: donald l bodenner, md            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: donald l bodenner associate professor
  More Information

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

Keywords provided by University of Arkansas:
megestrol acetate
adrenal insufficiency
adrenal suppression

Study placed in the following topic categories:
Adrenal Insufficiency
Epinephrine
Hypoadrenalism
Megestrol
Megestrol Acetate
Adrenal gland hypofunction

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009