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

NCT02100540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-02-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Changhua Christian Hospital

    collaborator OTHER

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-19
Primary Completion
2017-03-23
Completion
2017-09-28

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100540 on ClinicalTrials.gov