Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain
Recruitment status was Active, not recruiting
- 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).
Fibrocystic Disease of Breast
Fibrocystic Changes of Breast
Drug: IoGen (molecular iodine)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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|
- Total clinical breast pain as documented by patient daily diary.
- Change in fibrosis based upon breast examination.
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||March 2008|
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.
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|Study Director:||Julia Kazakhin, M.D.||Symbollon Pharmaceuticals, Inc.|