DESCRIPTION
Megace ® ES (megestrol acetate) oral suspension contains megestrol
acetate, a synthetic derivative of the naturally occurring steroid hormone,
progesterone. Megestrol acetate is a white, crystalline solid chemically
designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility
at 37° C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its
molecular weight is 384.52.
The chemical formula is
C24H32O4
and the structural formula is represented as follows:
Megace ® ES (megestrol acetate) is a concentrated formula supplied as
an oral suspension containing 125 mg of megestrol acetate per mL.
Megace ® ES (megestrol acetate) oral suspension contains the following
inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime
flavor, citric acid monohydrate, docusate sodium, hydroxypropyl methylcellulose
(hypromellose), natural and artificial lemon flavor, purified water, sodium
benzoate, sodium citrate dihydrate, and sucrose.
|
Megestrol Acetate Oral
Suspension Clinical Efficacy Trials |
|
Trial 1 |
Trial 2 |
|
Study Accrual Dates |
Study Accrual Dates |
|
11/88 to 12/90 |
5/89 to 4/91 |
Megestrol Acetate, mg/day |
0 |
100 |
400 |
800 |
|
0 |
800 |
Entered Patients |
38 |
82 |
75 |
75 |
|
48 |
52 |
Evaluable Patients |
28 |
61 |
53 |
53 |
|
29 |
36 |
Mean Change in Weight (lb.) |
|
|
|
|
|
|
|
Baseline to 12 Weeks |
0.0 |
2.9 |
9.3 |
10.7 |
|
-2.1 |
11.2 |
% Patients ≥ 5 Pound Gain |
|
|
|
|
|
|
|
At Last Evaluation in 12 weeks |
21 |
44 |
57 |
64 |
|
28 |
47 |
Mean Changes in Body Composition: |
|
|
|
|
|
|
|
Fat Body Mass (lb.) |
0.0 |
2.2 |
2.9 |
5.5 |
|
1.5 |
5.7 |
Lean Body Mass (lb.) |
-1.7 |
-0.3 |
1.5 |
2.5 |
|
-1.6 |
-0.6 |
Water (liters) |
-1.3 |
-0.3 |
0.0 |
0.0 |
|
-0.1 |
-0.1 |
% Patients With Improved Appetite: |
|
|
|
|
|
|
|
At Time of Maximum Weight Change |
50 |
72 |
72 |
93 |
|
48 |
69 |
At Last Evaluation in 12 Weeks |
50 |
72 |
68 |
89 |
|
38 |
67 |
Mean Change in Daily Caloric Intake: |
|
|
|
|
|
|
|
Baseline to Time of Maximum Weight Change |
-107 |
326 |
308 |
646 |
|
30 |
464 |
*Based on bioelectrical impedance analysis
determinations at last evaluation in 12 weeks |