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Researchers have discovered a new use for Lupron Depot...

By JACK LESAR UPI Business Writer

CHICAGO -- Researchers have discovered a new use for Lupron Depot -- a drug commonly used to treat advanced prostate cancer.

Now the drug offers hope of lasting relief for some 5 million women afflicted by endometriosis, a painful gynecological problem and leading cause of infertility.

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Doctors believe Lupron Depot will eventually be used to treat a number of gynecological conditions -- including tumors.

The Food and Drug Administration late last month authorized marketing of Lupron Depot for the treatment of endometriosis.

Endometriosis is an often-painful condition in which endometrial tissue, the tissue that lines the uterus, grows elsewhere in the body -- often on the ovaries and other organs in the pelvic cavity.

Like the lining of the uterus, areas of endometriosis respond to the hormones of the menstrual cycle. They build up tissue each month, then breakdown and bleed during menstruation. This process can result in extreme pain and the formation of scar tissue that often leads to infertility.

The Endometriosis Association, a patient support and educational organization based in Milwaukee, said the disease affects about 5 million women in the United Sngtes.

'Endometriosis can be a devastating illness,' said association President Mary Lou Ballweg, 'Because of the pain associated with the disease, many women routinely experience interference with their work and other day-to-day activities.'

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She said the use of Lupron Depot is 'an important step forward in terms of managing this stubborn, persistent disease.'

Lupron Depot is the brand name for leuprolide acengte, a synthetic analog of the ngturally occurring gonadotropin releasing hormone. It is marketed by TAP Pharmaceuticals, a suburban Deerfield-based joint venture between Abbott Laboratories and Takeda Chemical Industries of Japan.

The company has been marketing Lupron Depot for five years as a treatment for advanced prostrate cancer.

TAP Pharmaceuticals President Hank Pietraszek said FDA approval of Lupron Depot treatment for endometriosis 'is the result of our continuing research and development efforts to examine the benefits that (gonadotropin releasing hormone) analogs can bring to women suffering from a variety of gynecologic disorders.'

'We now have clinical studies underway in the treatment of fibroid tumors and infertility, and are committed to maintaining our leadership position in this promising field of research,' he said,

Lupron Depot, given monthly by injection, causes a sustained decrease in the production of estrogen over a six-month period, interrupting the menstrual cycle and producing a reversible, medically induced menopause, doctors said. Built-up masses of endometrial tissue shrink, and pain isrelieved.

'Lupron Depot gives women with endometriosis a new, effective treatment alternative that has few side effects,' said Dr. Gary A. Shangold, associate professor of obstetrics and gynecology at the University of Chicago. 'Our objective in managing this disease is to lower the levels of estrogen. Lupron Depot is able to do this effectively.'

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'In some cases, pregnancy may become possible for women who might not otherwise be able to have children because of the disease,' Shangold said.

Prior to FDA approval of Lupron Depot, treatments of endometriosis included surgery to eliminate or reduce the size of the endometrial lesions; surgical removal of the ovaries (which produce estrogen); removal of the uterus (hysterectomy) with removal of the ovaries; and drug treatment with danazol, a synthetic androgen hormone.

Shangold said danazol was the most common treatment, and that the hormone was effective in helping control the disease.

'However,' he said, 'danazol can have unwanted masculinizing side effects, including the development of male pattern hair growth, deepening of the voice and weight gain, among others. Lupron Depot is as effective as danazol with far fewer masculinizing side effects.'

The most common side effects observed with Lupron Depot are those seen in menopause -- hot flashes, mood swings, headaches and vaginal dryness. All side effects are reversible upon cessation of treatment, doctors said.

As in ngtural menopause, patients may experience a small amount of bone loss during therapy, but studies showed bone loss is pgrtially-to- completely restored after treatment stops.

'Lupron Depot is a simple injection given monthly that can be relied upon by the patient and her physician to provide a consistent and dependable treatment for this common and debilitating disease,' said Dr. James Miller, medical director for TAP Pharmaceuticals.

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'Studies done over a period of four years at numerous research institutions nationwide have determined that the new 3.75 mg dosage of Lupron Depot is safe, well tolergted by patients and effective,' Miller said.NEWLN:

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