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 study treatment. Throughout the study women monitor the presence and intensity of various types of pelvic pain, their menstrual cycle, and other symptoms. Possible effects of raloxifene on the menstrual cycle, lipids, bone density, and in altering mood, causing headaches or deep vein thrombosis are monitored. We have accrued 85 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 diagnostic 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. In the next year, we will evaluate the utility of serum and urine markers for the diagnosis of endometriosis, the relationship between pre-operative pain and the surgical findings, and the utility of intraoperative Marcaine instilled under the diaphragm in decreasing post-operative pain and nausea. In collaboration with the Endometriosis Association, we analyzed survey responses of almost 4000 women with surgically diagnosed endometriosis for their symptoms and coexisting conditions. Almost all responders had pain (99%), and many reported infertility (41%). In this cohort of women with endometriosis, the rates of self-reported diagnoses of hypothyroidism, fibromyalgia, chronic fatigue syndrome, autoimmune diseases, allergies, and asthma were all significantly greater than the published prevalence in the general U.S. female population.

Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2002
Total Cost
Indirect Cost
Name
U.S. National Inst/Child Hlth/Human Dev
Department
Type
DUNS #
City
State
Country
United States
Zip Code
Karp, Barbara Illowsky; Sinaii, Ninet; Nieman, Lynnette K et al. (2011) Migraine in women with chronic pelvic pain with and without endometriosis. Fertil Steril 95:895-9
Stegmann, Barbara J; Funk, Michele Jonsson; Sinaii, Ninet et al. (2009) A logistic model for the prediction of endometriosis. Fertil Steril 91:51-5
Wei, Qingxiang; St Clair, J Benjamin; Fu, Teresa et al. (2009) Reduced expression of biomarkers associated with the implantation window in women with endometriosis. Fertil Steril 91:1686-91
Stratton, Pamela; Sinaii, Ninet; Segars, James et al. (2008) Return of chronic pelvic pain from endometriosis after raloxifene treatment: a randomized controlled trial. Obstet Gynecol 111:88-96
Stegmann, Barbara J; Sinaii, Ninet; Liu, Shannon et al. (2008) Using location, color, size, and depth to characterize and identify endometriosis lesions in a cohort of 133 women. Fertil Steril 89:1632-6
Morrissey, Kelly; Winkel, Craig; Hild, Sheri et al. (2007) Struma ovarii coincident with Hashimoto's thyroiditis: an unusual cause of hyperthyroidism. Fertil Steril 88:497.e15-7
Parker, Jason D; Leondires, Mark; Sinaii, Ninet et al. (2006) Persistence of dysmenorrhea and nonmenstrual pain after optimal endometriosis surgery may indicate adenomyosis. Fertil Steril 86:711-5
Hearns-Stokes, Rhonda; Mayers, Chantal; Zahn, Christopher et al. (2006) Expression of the proto-oncoprotein breast cancer nuclear receptor auxiliary factor (Brx) is altered in eutopic endometrium of women with endometriosis. Fertil Steril 85:63-70
Potlog-Nahari, Clariss; Stratton, Pamela; Winkel, Craig et al. (2004) Urine vascular endothelial growth factor-A is not a useful marker for endometriosis. Fertil Steril 81:1507-12
Potlog-Nahari, Clariss; Feldman, Andrew L; Stratton, Pamela et al. (2004) CD10 immunohistochemical staining enhances the histological detection of endometriosis. Fertil Steril 82:86-92

Showing the most recent 10 out of 15 publications