Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

• ClinicalTrials.gov Identifier: NCT00575029
• Recruitment Status: Completed
• First Posted: December 17, 2007
• Results First Posted: August 29, 2011
• Last Update Posted: August 29, 2011
• Sponsor: University of Arkansas
• Information provided by: University of Arkansas

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adrenal Insufficiency	Drug: megestrol acetate	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate
• Study Start Date: April 2004
• Actual Primary Completion Date: December 2004
• Actual Study Completion Date: December 2004

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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).

Drug: megestrol acetate; 600 mg by mouth daily

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adrenal Insufficiency [ Time Frame: stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered ]
   Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered
2. Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function [ Time Frame: weekly for up to 6 weeks ]
   the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 80 Years (Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arkansas

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

• Principal Investigator: donald l bodenner; associate professor

More Information

• Responsible Party: Donald Bodenner MD, university of arkansas for medical sciences
• ClinicalTrials.gov Identifier: NCT00575029
• Other Study ID Numbers: 26835
• First Posted: December 17, 2007
• Results First Posted: August 29, 2011
• Last Update Posted: August 29, 2011
• Last Verified: July 2011

Keywords provided by University of Arkansas:

megestrol acetate; adrenal insufficiency; adrenal suppression

Additional relevant MeSH terms:

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Megestrol; Megestrol Acetate; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptives, Oral, Synthetic; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Appetite Stimulants; Central Nervous System Stimulants