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Study of GnRH receptor agonist for endometriosis pain begins
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Researchers have launched a phase 3 clinical program to assess the efficacy and safety of a gonadotropin-releasing hormone receptor antagonist for the treatment of women with endometriosis-associated pain, according to a press release from Myovant Sciences.
“Endometriosis is a very common and debilitating estrogen-driven disease that occurs in around 10% of premenopausal women,” Linda C. Giudice, MD, PhD, a reproductive endocrinologist and distinguished professor at the University of California, San Francisco School of Medicine. “Women with moderate to severe endometriosis-associated pain are in great need of well-tolerated medicines to help ease their pain and provide a treatment alternative to invasive procedures such as laparoscopy and hysterectomy.”
The clinical program consists of two trials, dubbed SPIRIT 1 and SPIRIT 2, each of which will enroll approximately 600 women with a confirmed endometriosis diagnosis. Participants will be randomized to the GnRH receptor antagonist (relugolix, Myovant) plus low-dose hormonal add-back therapy for 24 weeks, relugolix for 12 weeks followed by relugolix plus hormonal add-back therapy for 12 weeks, or placebo for 24 weeks.
The primary endpoints are reduction of dysmenorrhea and reduction in nonmenstrual pelvic pain. Safety will be assessed through bone mineral density.