Release Date: 06/12/2014
Researchers in the Center for Reproduction and Infertility at Women & Infants Hospital of Rhode Island have launched an arm of the national SOLSTICE clinical study, evaluating the safety and effectiveness of an investigational drug to help women with moderate to severe endometriosis pain symptoms.
"The goal of SOLSTICE is to evaluate an orally active gonadotropin-releasing hormone (GnRH) antagonist in the management of endometriosis-related pain," explains Kelly Pagidas, MD, interim director of the Center for Reproduction and Infertility and principal investigator of the Women & Infants arm of the study.
Endometriosis is the growth of tissue lining the uterus outside of the uterus on other organs or structures in the body, most commonly on the ovaries, Fallopian tubes, the outer surface of the uterus or the lining of the pelvic cavity. At least 5.5 million women in North America have endometriosis, which can lead to very painful cramps or periods, heavy periods, chronic pelvic pain, intestinal pain, and infertility.
"The pain from endometriosis can range from mild to severe with some women experiencing extreme pain," Dr. Pagidas says. "To qualify for this study, women must experience moderate or severe pain during their period as well as non-menstrual pelvic pain."
Currently, physicians can prescribe non-steroidal anti-inflammatory drugs (NSAIDS), oral contraceptives, and injectable GnRH agonists and antagonists.
SOLSTICE involves approximately 14 study visits, for which women will be compensated. Women are eligible to join the study if they:
- Are 18 to 49 years old and have not gone through menopause
- Have been surgically diagnosed with endometriosis in the past 10 years and have pain symptoms during their period and at other times during their menstrual cycle
- Are not taking pain medication to treat a chronic disease other than endometriosis
- Do not have a history of osteoporosis or another bone disease
- Are not pregnant or breastfeeding or planning to get pregnant in the next 24 months
All investigational study medication and study-related tests and procedures will be free for SOLSTICE participants. Participants will also be compensated for costs associated with study visits.
To volunteer for the SOLSTICE study, women can go to SolsticeResearch.com, text ENDO1 to 87888, or call Courtney Bodge, PhD, at the Center for Reproduction and Infertility at (401) 453-7500, ext. 48422.
About Women & Infants Hospital
Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility. It is home to the nation’s first mother-baby perinatal psychiatric partial hospital, as well as the nation’s only fellowship program in obstetric medicine.
Women & Infants has been designated as a Breast Imaging Center of Excellence by the American College of Radiography; a Center of Excellence in Minimally Invasive Gynecology; a Center of Biomedical Research Excellence by the National Institutes of Health (NIH); and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute’s Gynecologic Oncology Group and the Pelvic Floor Disorders Network.