A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women

  • STATUS
    Not Recruiting
  • participants needed
    60
  • sponsor
    Yung Shin Pharm. Ind. Co., Ltd.
Updated on 21 January 2021
heat
hysterectomy
estrogen
progestin
tamoxifen
aromatase inhibitor
risperidone
dopaminergic
sever
serm
flashes
hot flashes

Summary

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.

Details
Condition Premenstrual syndrome, Hot flushes
Treatment I placebo capsule, II RDC 0.3mg capsule, III RDC 0.6mg capsule
Clinical Study IdentifierNCT02100540
SponsorYung Shin Pharm. Ind. Co., Ltd.
Last Modified on21 January 2021

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