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

    July 2025 in “ Annals of Medicine ”
    André Luiz Malavasi Longo de Oliveira, Camilla Moreira Ribeiro, Leandro Barile Agati, Agnaldo Lopes da Silva Filho, Charles Berger, Eduardo Schor, Ana Comin, Eduardo José Bezerra Neto, Taís Helena de Oliveira, Polyana Raposo Caldas, Francisco J. P. Lopes, Nathalia Westphalen, Francisleny Vieira, Eduardo Augusto Rabelo Socca, Daniele Komar, Eduardo Ramacciotti
    TLDR Gestrinone pellets may help reduce pelvic pain in endometriosis safely.
    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.
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