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NCT00575029 · ClinicalTrials.gov registry record · NA

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

A NA study, sponsored by University of Arkansas.

Completed
Registry status
NA
Development phase
7
Enrollment target

NCT00575029 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 7 participants.

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The verdict

NCT00575029, a NA study, has completed, sponsored by University of Arkansas.

COMPLETED
Registry status
NA
Development phase
7 participants
Enrollment target

Study 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.

Interventions

  • DRUG megestrol acetate

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2004-04
Est. Completion 2004-12
Phase NA

Sponsor

University of Arkansas

318 total trials

What the Registry Record Tells You About NCT00575029

The ClinicalTrials.gov registry entry for NCT00575029 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which megestrol acetate is the first listed.

NCT00575029 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00575029 about?

NCT00575029 is a clinical study titled "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 mechani...

What is the current status of trial NCT00575029?

This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2004-04. Estimated completion is 2004-12.

What interventions are being tested in trial NCT00575029?

The interventions under investigation include: megestrol acetate (DRUG).

Who is sponsoring clinical trial NCT00575029?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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