This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.
The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
1 tablet daily
1 tablet daily
Mean change in average frequency of moderate to severe hot flashes
Time frame: Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Time frame: Baseline to Day 28 and to Day 84
Safety and tolerability of Cenestin 0.3mg
Time frame: Throughout study
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