Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic antagonism. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
I placebo capsule
II RDC 0.3mg capsule
III RDC 0.6mg capsule
Changhua Christian Hospital
Changhua, Taiwan
Mean change in frequency of moderate to severe vasomotor symptoms
Time frame: baseline to weeks 4 and 12
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