Gestrinone versus a gonadotropin-releasing hormone agonist for the treatment of pelvic pain associated with endometriosis: a multicenter, randomized, double-blind study. Gestrinone Italian Study Group

Abstract

Objectives: To evaluate the efficacy of gestrinone versus leuprolide acetate (LA) in improving pelvic pain in women with endometriosis and to compare their effects on bone mineral density and serum lipid profile.

Design: Multicenter, double-blind, double-dummy, randomized clinical trial.

Setting: Six academic departments specialized in the study of endometriosis.

Patient(s): Fifty-five women with moderate or severe pelvic pain and laparoscopically diagnosed endometriosis.

Intervention(s): Six-month treatment with oral gestrinone (n = 27) or IM depot LA (n = 28) followed by 6-month follow-up.

Main outcome measure(s): Variations in severity of dysmenorrhea, deep dyspareunia, and nonmenstrual pain as shown by a visual analog scale and a verbal rating scale, modifications in bone mineral content as shown by dual-roentgenogram absorptiometry, and variations in serum cholesterol subfractions and lipoprotein(a) concentrations.

Result(s): Significant improvements were observed in all three symptoms considered in both treatment arms. Moderate or severe pain symptoms recurrence on both pain scales was observed in 2 of 17 (11.8%) patients given gestrinone compared with 9 of 17 (52.9%) of those given LA (odds ratio, 0.12; 95% confidence interval, 0.02 to 0.69). Lumbar bone mineral density increased slightly in the gestrinone group but decreased by 3% in the LA one. High-density-lipoprotein cholesterol fell by 25% and lipoprotein(a) decreased by approximately 40% in the gestrinone-treated women but did not vary in those receiving LA.

Conclusion(s): Oral gestrinone is at least as effective as depot LA for pain relief in women with symptomatic endometriosis. A tendency to prolonged pain reduction was observed after gestrinone compared with LA treatment. Gestrinone does not negatively affect bone density but variations in serum lipids need further evaluation.