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 Author Bio
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Currently selected section: Protocol Schema
Protocol Background
Protocol Goals
Patient Eligibility
Test Schedule
Stratification Factors
Registration/Randomization
Protocol Treatment
Dosage Modification
Ancillary Treatment
Toxicity Monitoring
Treatment Evaluation
Descriptive Factors
Treatment/Follow-up
Pharmacologic Studies
Drug Information
Statistical Considerations
Pathology Considerations
Records/Data Collection Procedures
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Appendices

 

Chapter 2B: Development of a Clinical Trial for Hot Flash Protocol: Protocol Schema
 

        

 

 

 

 


Double-Blind, Crossover, Placebo-Controlled

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Randomization to either: Baseline symptom documentation to SOYEST to Placebo to Off Study or SOYEST Open-Label. OR Baseline symptom documentation to Placebo SOYEST to SOYEST Open-Label to Off-study except for Nurse phone calls at 6, 12 and 24 months.

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