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

* 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).

Sex

Female

Minimum age

18 Years

Maximum age

50 Years

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

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