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Symbollon is seeking volunteers to participate in a Phase III clinical trial. The trial is designed to evaluate the effectiveness of a novel iodine-based drug, IoGen, in treatment of moderate or severe breast pain associated with fibrocystic breast disease (FBD). There are scientific data that explore the relationship between iodine and mammary tissue. At least three previous human clinical studies indicate that iodine can effectively treat the symptoms associated with FBD.

Participants will receive either a trial drug or placebo pill (which contains no active medication) for 6 months. Participation in the study will require 2 initial screen visits, qualified participants will be asked to schedule 6 more study visits and to complete a short daily pain diary while they are in the study. Participants will be compensated for the time and travel.

WHAT IS CLINICAL BREAST PAIN?
Breast pain, or mastalgia, in most cases is a benign breast syndrome. Survey data suggested that about 65% of premenopausal women regularly experience up to 4 days of breast pain, tenderness and/or swelling during menstrual cycle. Breast pain may be associated with the menstrual cycle (cyclic mastalgia) or not (non-cyclic mastalgia). Physicians recognize two types of cyclic breast pain based on pain severity and length: symptomatic pain, which is considered “normal” and lasts up to 4 days, and “clinical” which is more severe, prolonged (6 days and longer) type of pain. Cyclic breast pain occurs in both breasts and it may differ from month to month but always gets worse before a period and it may be associated with breast lumps and/or breast thickening, sometimes referred to as FBD.

Women most frequently describe their breast discomfort as: sharp shooting pain, dull aching pain, pain from movement and pain from pressure. Commonly women can not perform some or all of their everyday, normal activities, they can not hug their loved ones, their breasts are very painful when anything touches them, and analgesics do not relieve such pain.

The causes of breast pain are not well understood, however, the most reasonable explanation of breast pain is subtle hormonal imbalance.

WHAT IS FIBROCYSTIC BREAST DISEASE?
Fibrocystic breast disease (FBD) is benign (non-cancerous) changes in the tissues of the breast. The condition is so commonly found in breasts, it is believed to be a variation of normal; therefore many clinicians consider the term "disease" to be misleading and prefer to use term "change". It is estimated that more than 60% of women between the ages of 30 and 50 will experience such change during their lifetime. Symptoms of FBD include: a dense, irregular and lumpy "cobblestone" consistency of the breast tissue; periodic or persistent breast discomfort; fullness of breast(s); dull, heavy pain and tenderness; premenstrual tenderness and swelling. Symptoms typically peak just before each menstrual period, and improve immediately after the menstrual period.

Women often discover the existence of this condition when during their monthly breast self-exam. As frightening as it may be it's important to remember that most breast lumps are not breast cancer. However, all breasts lumps must be investigated to rule out breast cancer and/or to begin immediate treatment if breast cancer is diagnosed.

The cause of FBD is not completely understood, but the changes are believed to be associated with ovarian hormones since the condition usually subsides with menopause, and may vary in consistency during the menstrual cycle. There is no safe and effective treatment for FBD. Oral contraceptives and synthetic androgen may be prescribed in severe cases, when the potential benefit is thought to outweigh the potential adverse effects. The effectiveness of Vitamin E, Vitamin B-6, herbal preparations, such as evening primrose oil, and dietary changes are somewhat controversial and have been questioned in recent randomized trials.