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

 

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

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11.1 During the seven-day baseline symptom documentation period and the randomized double-blind study, patients will be instructed to complete a daily questionnaire (Appendix III) at roughly the same time each day to document severity and frequency of hot flashes and side effects of treatment. Similar data (Appendix VI) will also be requested should the patient enter the optional continuation study.

11.2 At the conclusion of the double-blind study, each patient will be asked to document which treatment is preferred.


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