Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

NCT ID: NCT00575029

Last Updated: 2011-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2004-12-31

Brief Summary

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.

Conditions

Adrenal Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

megace treatment

Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods).

Group Type: EXPERIMENTAL

megestrol acetate

Intervention Type: DRUG

600 mg by mouth daily

Interventions

megestrol acetate

600 mg by mouth daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

university of arkansas for medical sciences

Principal Investigators

donald l bodenner

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

26835

Identifier Type: -

Identifier Source: org_study_id