A clinical trial for a much needed treatment option for pain associated with fibrocystic breast disease, is in progress nationwide. The severely debilitating symptoms such as breast pain, affects about 26 million women in the United States alone but is often left untreated leaving women feeling hopeless.
As many as 50% of American women talk to their physician about breast pain including swelling, tenderness and lumps that increase prior and during menstruation and may continue for several days. The pain is not only physical. Psychological stress is often associated with undergoing mammograms, ultrasound scans and breast biopsies, techniques frequently utilized by physicians to rule out other diseases of the breast.
"Breast pain associated with fibrocystic breast disease can be physically impairing, leaving women unable to cope with basic daily functions, yet 85% of women don't receive treatment," said Gerianne Tringali DiPiano, President and CEO of FemmePharma Global Healthcare, the company sponsoring the study. "We hope news of this trial will compel women with breast pain associated with fibrocystic breast disease who have been previously diagnosed to seek a study center in their area."
Physicians at centers nationwide will enroll women who have breast pain associated with fibrocystic breast disease.
"The trial allows us to assess a new dosage form of an active pharmaceutical ingredient with a demonstrated safety and efficacy profile. We expect that the new dosage forms will provide a new treatment option for this very important disease state," added Bruce J. Levine MD, FACOG, and investigator of the trial.
About Breast Pain
Breast pain can impair a woman's ability to work, participate in her daily activities, embrace a child or have an intimate relationship with her partner. In addition, breast pain frequently causes increased anxiety and stress in a woman's life as a result of dealing with pain each month.
Approximately 15% of women who experience breast pain require prescription medication. Currently there is only one FDA approved prescription medication for pain associated with fibrocystic breast disease. However, this medication typically produces unwanted systemic side effects, which often causes women to stop their necessary treatment. In many cases, women are sent home and told to ice their breasts or purchase a tighter fitting brassiere leaving them feeling hopeless.