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Cenestin
Clinical Pharmacology
Cenestin
Cenestinb 0.625 mg and 2 x 0.625 mg (n=70)
Placebo (n=47)
Mean # (SD)
96.8 (42.6)
94.1 (33.9)
-
Week 4
Mean # (SD)
28.7 (28.8)
45.7 (36.8)
-
Mean Change from Baseline(SD)
-68.1 (43.9)
-48.4 (46.2)
P-value vs.Placebo
p=.022
Week 12
Mean # (SD)
16.5 (25.7)
37.8 (38.7)
-
Mean Change from Baseline(SD)
-80.3 (50.3)
-56.3 (48.0)
P-value vs.Placebo
p=.010
Mean = Arithmetic Mean, SD = Standard Deviation
a Intent-to-treat population = 117
b Combined results for 0.625 mg and 0.625 mg Cenestin tablets.
| Table 3 Clinical Response* Mean Change in the Number of Moderate to Severe Hot Flushes Per Week, 0.45 mg Cenestin, ITT Population | |||
|
Cenestin 0.45 mg(n=53) |
Placebo(n=51) | ||
|
Baseline | |||
|
Mean # (SD) | 95.9 (37.0) | 95.9 (41.6) | - |
|
Week 4 | |||
|
Mean # (SD) | 45.7 (45.9) | 59.4 (46.2) | - |
|
Mean Change from Baseline(SD) | -50.3 (35.4) | -36.5 (42.9) | |
|
P-value vs.Placebo | p=.014 | ||
|
Week 12 | |||
|
Mean # (SD) | 26.1 (43.0) | 50.5 (48.4) | - |
|
Mean Change from Baseline(SD) | -69.9 (38.1) | -45.4 (44.7) | |
|
Brand Name: Cenestin
Generic Name: Synthetic conjugated estrogens
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