NCT02100540

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

A Randomized, Placebo-Controlled, Double-Blind, Dose-Response, Phase 2, -Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• PMS
• Hot Flashes

Interventions

Type	Name	Description
DRUG	I placebo capsule	I placebo capsule
DRUG	II RDC 0.3mg capsule	II RDC 0.3mg capsule
DRUG	III RDC 0.6mg capsule	III RDC 0.6mg capsule

Timeline

• Start date: 2014-03-19
• Primary completion: 2017-03-23
• Completion: 2017-09-28
• First posted: 2014-04-01
• Last updated: 2022-02-14

Locations

1 site across 1 country: Taiwan