research Rationale and design of the GLADE study: a randomized, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of gestrinone subdermal bioabsorbable pellet in endometriosis-related pelvic pain
The GLADE study is a randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of gestrinone subdermal bioabsorbable pellets in treating pelvic pain related to endometriosis. It involves 100 participants with deep infiltrative endometriosis who did not respond satisfactorily to surgery. Participants are randomly assigned to receive either gestrinone pellets or a placebo, alongside a levonorgestrel-releasing intrauterine system, over a 6-month period. The primary endpoint is the occurrence of serious adverse events (SAEs) within 6 months, with additional evaluations on androgenization, laboratory changes, pelvic pain intensity, and quality of life. The study aims to provide insights into the safety, tolerability, and pharmacokinetics of gestrinone pellets, potentially informing clinical practice for endometriosis treatment.
