Working… Menu
Trial record 3 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00575029
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Information provided by:
University of Arkansas

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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

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

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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00575029

Layout table for location information
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Layout table for investigator information
Principal Investigator: donald l bodenner associate professor

Layout table for additonal information
Responsible Party: Donald Bodenner MD, university of arkansas for medical sciences Identifier: NCT00575029     History of Changes
Other Study ID Numbers: 26835
First Posted: December 17, 2007    Key Record Dates
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:
Layout table for MeSH terms
Respiratory System Agents
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Megestrol Acetate
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Vasoconstrictor Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents