Trial Outcomes & Findings for Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate (NCT NCT00575029)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

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

Results posted on

2011-08-29

Participant Flow

Recruitment 4/04 to 7/04.

Participant milestones

Participant milestones
Measure	Megestrol Acetate Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Megestrol Acetate n=7 Participants Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	68 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Megestrol Acetate n=7 Participants Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Number of Participants With Adrenal Insufficiency	7 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Megestrol Acetate n=7 Participants Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 1	6 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 2	2 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 3	2 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 4	2 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 5	2 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 6	2 weeks
Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function participant 7	2 weeks

Adverse Events

Megestrol Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Donald Bodenner

University of Arkansas

Phone: 501-526-5710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place