Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

NCT00575029 | Completed Results

• 1 other identifier: 26835
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

megestrol acetate; adrenal insufficiency; adrenal suppression

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adrenal Insufficiency

  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

  stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered

• Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function

  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)

  weekly for up to 6 weeks

Study Arms (1)

megace treatment

EXPERIMENTAL

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

Interventions

megestrol acetate DRUG

600 mg by mouth daily

megace treatment

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

funding became an issue limiting the number of patients enrolled

Results Point of Contact

• Title: Dr. Donald Bodenner
• Organization: University of Arkansas

bodennerdonald@uams.edu

501-526-5710

Study Officials

• donald l bodenner

  associate professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: April 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: August 29, 2011
• Results First Posted: August 29, 2011

Record last verified: 2011-07

Locations

US (1)