We are conducting a randomized, double blind placebo controlled study of surgery with or without raloxifene, EvistaTM for the treatment of pain from endometriosis. This study evaluates whether a selective estrogen receptor modulator, raloxifene, could prevent the regrowth of endometriosis and return of pain in women with pelvic pain from endometriosis. At the first study surgery, all women have laser excision of endometriosis during a laparoscopy. Those with biopsy proven disease are randomized to raloxifene or placebo. Throughout the study women monitor the presence and intensity of various types of pelvic pain, their menstrual cycle, and other symptoms. The effect of raloxifene on the menstrual cycle, lipids, and bone density are monitored. Women are also monitored for mood changes and the occurrence of headaches or deep vein thrombosis. A related goal is to identify non-invasive markers or diagnostic tests for endometriosis. We have accrued 115 women. To date, we have examined the usefulness of MRI in diagnosing endometriosis and correlated histopathology with laparoscopic findings. Our analysis suggests that MRI has limited utility in a cohort of women with pelvic pain because it has a low detection rate of biopsy proven endometriosis lesions and is relatively insensitive in determining whether an individual woman has endometriosis. In comparing surgical and histopathologic findings, only about 70% of endometriosis lesions seen at surgery are biopsy proven. Comorbidities of endometriosis including autoimmune and other disease states. We analyzed a survey of almost 4000 women with surgically diagnosed endometriosis conducted by the Endometriosis Association. Almost all responders had pain (99%), and many reported infertility (41%). In this cohort of women with endometriosis, hypothyroidism, fibromyalgia, chronic fatigue syndrome, autoimmune diseases, allergies, and asthma are all significantly more common than in women in the general U.S. population.
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