Doctors at Northwestern Memorial Hospital and Northwestern University's Feinberg School of Medicine are testing the effectiveness of an investigational drug, ERB-041, to relieve pelvic pain and inflammation due to endometriosis, a chronic condition that affects more than 5.5 million American women. Endometriosis is caused when tissue similar to the lining of the uterus grows elsewhere in the body, causing chronic pelvic pain, painful menstruation and painful intercourse, and often limits a woman's ability to carry out normal daily activities.
"While some current treatments for endometriosis may be effective for a short period of time, they also often have significant side effects," explains Lee Shulman, MD, medical director, Reproductive Genetics, Northwestern Memorial Hospital, Professor of Obstetrics and Gynecology at Northwestern University's Feinberg School of Medicine, and principal investigator on the arm of the study being conducted at Northwestern. "For example, one of the most commonly used treatments for endometriosis today are gonadotropin- releasing hormones (GnRH) analogs. This group of drugs decreases the production of estrogen to the levels a woman has after menopause, causing side effects such as bone loss, hot flashes, and mood swings."
ERB-041 is an experimental medication that selectively works to target a recently discovered receptor, estrogen receptor-β (ERβ). Receptors are very specialized protein molecules that sit on the surface of cells in the body. They act like an on-off switch for a particular activity in the cell. If the right substance comes along that fits the receptor -- like a key fitting into a lock -- the switch is turned on and a particular activity in the cell begins. "ERB-041 is a 'key' for ERβ, and in preclinical models can cause endometriosis lesion regression," explains Dr. Shulman. "Because ERB-041 is highly selective for ERβ, it does not affect reproductive organs like nonselective estrogens, such as those found in oral contraceptives."
ERB-041 has dramatic beneficial effects in a mouse model of endometriosis and may be useful in treating the human disease. How ERB-041 works in this model is not well understood, but it may involve both an effect on endometriotic lesions as well as on the pain they cause.
This research study is a double-blind randomized, placebo-controlled, dose-ranging study. Each participant will be in the study for approximately 22 weeks. There will be a screening period (approximately eight weeks), a 12-week treatment period, and a 15-day follow-up period. Participants who meet the following criteria are eligible for screening:
A woman between the ages of 18 and 45 with regular menstrual periods Have endometriosis diagnosed by a surgical procedure (laparoscopy or laparotomy) within the past three years. Have moderate to severe pelvic pain due to endometriosis for at least three months before screening. Not using oral contraceptives within 30 days before screening Be sexually active Have not had a surgical treatment for endometriosis within three months before screening.
Those interested in participating in this clinical trial should call 312-926-6631 for more information.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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