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

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

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ClinicalTrials.gov Identifier: NCT00575029
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Sponsor:
Information provided by:
University of Arkansas

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Adrenal Insufficiency
Intervention Drug: megestrol acetate
Enrollment 7
Recruitment Details Recruitment 4/04 to 7/04.
Pre-assignment Details  
Arm/Group Title Megestrol Acetate
Hide Arm/Group Description Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Megestrol Acetate
Hide Arm/Group Description Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
7
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
68  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Participants With Adrenal Insufficiency
Hide 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
Time Frame stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Megestrol Acetate
Hide Arm/Group Description:
Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
7
2.Primary Outcome
Title Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function
Hide 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)
Time Frame weekly for up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Megestrol Acetate
Hide Arm/Group Description:
Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: weeks
participant 1 6
participant 2 2
participant 3 2
participant 4 2
participant 5 2
participant 6 2
participant 7 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Megestrol Acetate
Hide Arm/Group Description Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
All-Cause Mortality
Megestrol Acetate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Megestrol Acetate
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Megestrol Acetate
Affected / at Risk (%)
Total   0/7 (0.00%) 
funding became an issue limiting the number of patients enrolled
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Donald Bodenner
Organization: University of Arkansas
Phone: 501-526-5710
EMail: bodennerdonald@uams.edu
Layout table for additonal information
Responsible Party: Donald Bodenner MD, university of arkansas for medical sciences
ClinicalTrials.gov Identifier: NCT00575029     History of Changes
Other Study ID Numbers: 26835
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: March 31, 2011
Results First Posted: August 29, 2011
Last Update Posted: August 29, 2011