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

• Status: Unknown status
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

• 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symbollon Pharmaceuticals
• Treatments: Cadexomer iodine; Iodine

Criteria

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