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Completed

NCT Number: NCT00575029

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

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.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Megestrol acetate

Drug

600 mg by mouth daily

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Evaluation of the Time Course of Adrenal Suppression and Adrenal Recovery After Ingestion of Megestrol Acetate

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Dec 17, 2007
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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