Clinical Trial: Study for Treatment of Moderate or Severe, Periodic, "Cyclic", Breast Pain

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

  • 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).

    • Detailed Summary:

    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.


    Sponsor: Symbollon Pharmaceuticals

    Current Primary Outcome: Total clinical breast pain as documented by patient daily diary.

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Change in fibrosis based upon breast examination.

    Original Secondary Outcome: Same as current

    Information By: Symbollon Pharmaceuticals

    Dates:
    Date Received: October 7, 2005
    Date Started: July 2005
    Date Completion: March 2008
    Last Updated: June 15, 2007
    Last Verified: June 2007