Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis

M D Hornstein, Hornstein MD, Mark D. Hornstein, R Hemmings, Robert Hemmings, Hemmings R, Yuzpe AA, A A Yuzpe, A. Albert Yuzpe, W L Heinrichs, Heinrichs WL
Fertility and Sterility · 1997 · vol. 68(5) , pp. 860–864 · doi:10.1016/s0015-0282(97)00360-9 · PMID:9389816 · W2012656826
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This study investigated the efficacy of nafarelin compared to placebo in reducing endometriosis recurrence following laparoscopic surgery.

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Abstract

ObjectiveTo evaluate the efficacy of the GnRH agonist (GnRH-a) nafarelin compared with placebo administered for 6 months after reductive laparoscopic surgery for symptomatic endometriosis.DesignRandomized, prospective, placebo-controlled, multicenter clinical trial.SettingThirteen clinics including private practice and university centers.Patient(s)One hundred nine women aged 18-47 with laparoscopically proven endometriosis and pelvic pain who had undergone reductive laparoscopic surgery for endometriosis.Intervention(s)Patients were randomized to receive either the GnRH-a nafarelin (200 micrograms twice daily) or placebo for 6 months.Main outcome measure(s)Time to initiation of alternative treatment (the length of time from beginning study medication to receiving alternative therapy or to deeming that the study drug was ineffective) and patient-reported and physician-assessed pelvic pain scores.Result(s)The median time to initiation of alternative treatment was > 24 months in the nafarelin group versus 11.7 months in the placebo group. Fifteen (31%) of 49 nafarelin-treated patients required alternative therapy, compared with 25 (57%) of 44 placebo-treated patients. The patients' pelvic pain scores dropped significantly in the nafarelin and placebo groups after 6 months of treatment. Physician summary ratings showed significant improvement in the nafarelin group and no significant changes in the placebo group after 6 months of treatment.Conclusion(s)Compared with placebo, nafarelin administered after reductive laparoscopic surgery for endometriosis significantly delays the return of endometriosis symptoms requiring further treatment.

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Hormones Laparoscopy Nafarelin Adolescent Adult Combined Modality Therapy Endometriosis Endometriosis Female Hormones Humans Middle Aged Nafarelin Placebos Prospective Studies

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