Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women with Polycystic Ovary Syndrome

The study assessed the safety and efficacy of elagolix, a GnRH antagonist, in treating polycystic ovary syndrome (PCOS) in a phase 2 trial with 114 women. The primary goal was to normalize menstrual cycles, but only 3 participants achieved this, showing no significant improvement over placebo. Elagolix reduced luteinizing hormone (LH) levels but did not affect follicle-stimulating hormone (FSH) levels or menstrual cycle regulation. Adverse events were similar across groups. The study concluded that elagolix did not effectively normalize ovulatory cycles in PCOS patients, suggesting it might not be suitable for treating PCOS alone. Future research could explore lower doses or combination therapies. Limitations included small sample sizes and early discontinuation.