Pain Clinical Trial
Official title:
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of IoGen™ for the Treatment of Moderate or Severe, Periodic Breast Pain Associated With Symptomatic Fibrocystic Breast Disease
- History of clinical breast pain for at least the last six months.
- At least six days of moderate or severe breast pain per cycle.
- Fibrosis, cysts, nodules involving at least 25% of the surface of one breast.
- Euthyroid with no prior history of thyroid disease.
- Six months of daily therapy with molecular iodine.
- Placebo controlled vs active (1:1).
Primary efficacy parameters will be measured by patient self-assessment of pain/tenderness
using a categorical daily pain diary. Clinical pain is defined as a patient assessment of
moderate or severe pain for any given day. Total clinical pain per menstrual cycle is
calculated based upon the categorical ratings recorded in a patient’s daily pain diary over
the course of a complete menstrual cycle.
A directed breast examination will be used as a secondary efficacy endpoint. Changes in the
brest examination will be determined by the physician after consideration of both the nature
of the examination findings and the surface area of breast involvement. Changes as noted
after six months of therapy, relative to the screening visit (baseline) will be used to
evaluate this endpoint.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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