SAN ANTONIO (Sept. 15, 2014) ― When Brittany Barnhill was 12, the pain each month from her menstrual cramps was so intense that her mother took her to see the doctor. “I was misdiagnosed for three or four years, but when I was 17 they confirmed that I had endometriosis,” Barnhill said.
“At one time, I was taking four different pain medications and nothing worked. On a scale of 1 to 10, my pain was a 9, and there were side effects, too,” she said.
Clinical trial to evaluate new pain medication
That is why Barnhill, now 24, is now participating in a study being conducted by Randal Robinson, M.D. He is a reproductive endocrinology and infertility specialist who sees patients at UT Medicine San Antonio, the clinical practice of the School of Medicine at The University of Texas Health Science Center at San Antonio.
Endometriosis is a condition in which endometrial implants, similar to the tissue that normally lines the uterus, grow into the abdominal cavity, or attach to the fallopian tubes or ovaries. The endometrial implants undergo monthly changes similar to the lining of the uterus, but since they cannot leave the body through menstruation, they can become inflamed and scar the tissues they are attached to, resulting in pain and infertility.
5 million U.S. women diagnosed with endometriosis
Six to 10 percent of women of reproductive age ― about 5 million women in the United States ― have endometriosis, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development. And endometriosis has been diagnosed in 71 to 87 percent of women with chronic pelvic pain, according to the American Congress of Obstetricians and Gynecologists.
“No one knows exactly what causes endometriosis, but some women have such severe pain that they can’t function, work or take care of their kids,” Dr. Robinson said. Other symptoms can include pain during sexual intercourse, heavy bleeding and chronic pelvic pain.
“Other unusual facts about endometriosis are that it can be difficult to diagnose and the number of implants do not always correlate with the severity of the symptoms. Some women may have only one or two lesions but have the worst pain, while someone else might have Stage 4 ― the worst lesions ― but hardly any pain. It is completely individual,” Dr. Robinson said.
Many medications are used to treat endometriosis, such as oral contraceptive pills and pain medications, including narcotics. However, these medications have limitations. Currently, the best treatment for endometriosis is gonadotropin-releasing hormone, also known as GnRH agonists. Since this type of medication shuts down the menstrual cycle, women get the relief of no longer having periods, but at the cost of experiencing the symptoms of menopause, including hot flashes and loss of bone mineral density, which can weaken bones. The medication is given by injection in the doctor’s office. While it is a long-lasting, it can take several weeks to begin working, and during that time it can actually make the endometriosis symptoms worse until the drug takes full effect.
New medication being evaluated in clinical trial
The oral medication in the study Dr. Robinson is testing is Elagolix, a nonpeptide GnRH antagonist. This medicine directly blocks the GnRH receptor, so it works faster without initially worsening the effects of endometriosis, and theoretically will cause fewer menopausal symptoms. Doses can easily be adjusted or discontinued, and the medicine is not a narcotic.
The Phase 3 study, sponsored by AbbVie, is evaluating the safety, tolerability and effectiveness of Elagolix as a pain medication in women with moderate to severe endometriosis.
To participate in the clinical trial, call the research coordinator, Carann Easton, RN, at 210-567-6245 or 210-392-6952 (cell). You can also visit www.TheSolsticeStudy.com or ClinicalTrials.gov for more information.
UT Medicine San Antonio is the clinical practice of the School of Medicine at the UT Health Science Center San Antonio. With more than 700 doctors – all School of Medicine faculty members – UT Medicine is the largest medical practice in Central and South Texas. Expertise is in more than 100 medical specialties and subspecialties. Primary care doctors and specialists see patients in private practice at UT Medicine’s flagship clinical home, the Medical Arts & Research Center (MARC), located at 8300 Floyd Curl Drive, San Antonio 78229. Most major health plans are accepted, and UT Medicine physicians also practice at several local and regional hospitals. Call (210) 450-9000 to schedule an appointment, or visit www.UTMedicine.org for a list of clinics and phone numbers.