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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

NCTNCT00575029 (opens ClinicalTrials.gov in a new tab)Other id26835
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
7 participants (actual)
Sponsor
University of Arkansas · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Apr 2004
Primary completion
Dec 2004
Completion
Dec 2004
First posted
17 Dec 2007 (estimated)
Last update posted
29 Aug 2011 (estimated)
Conditions
Adrenal Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005
  1. N/A

    Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

    NCT00575029

    Apr 2004 to Dec 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • megestrol acetateDrug

Arms1

  • 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).

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adrenal Insufficiency

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

    Registry description

    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

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Number of Participants With Adrenal Insufficiency

GroupValue (participants)
Megestrol Acetate7
Primary outcomeNumber· weekly for up to 6 weeks

Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function

GroupValue (weeks)
Megestrol Acetate6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Megestrol AcetateStudy subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.–0 / 70 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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