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Cenestin

Clinical Pharmacology
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Clinical Pharmacology

Cenestinb 0.625 mg and 2 x 0.625 mg (n=70)

Placebo (n=47)

Baseline

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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