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

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.

Inclusion Criteria:

• History of clinical breast pain.
• Documentation of 6 or more sequential days of moderate or severe pain by patient daily diary.
• Conservative measures such as local heat, non-prescription analgesics, and properly fitted garments are not effective for the treatment of symptoms
• Euthyroid with no prior history of thyroid disease.
• Premenopausal female between the ages of 18 and 50.
• The presence of at least one palpable structure (nodules, cysts) and involvement (diffuse nodularity or breast thickening) of at least 25% of at least one breast surface.

Exclusion Criteria:

• History of thyroid disease
• Non-cyclic breast pain
• Treatment with gonadotropin releasing hormone (GnRH) agonist, Danocrine, tamoxifen, raloxifene, or bromocriptine within three months of starting the trial
• Initiation or change of any hormonal therapy within 6 months of enrollment; including birth control pills, hormone replacement therapy, any progestin including Norplant or Depo-Provera;
• Current treatment with iodine or iodine-containing medications or diagnostics
• Known hypersensitivity to iodine-containing products
• Breast implants;
• Oophorectomy (complete or partial)
• Uncontrolled hypertension;
• Breast biopsy breast biopsy within two months of screening; or expectation of a breast biopsy during the study for a suspicious mass present at baseline;
• Pregnant women or nursing mothers
• History of malignancy within the previous 5 years other than basal cell or squamous cell carcinoma of the skin
• History of breast cancer