Prospective randomized double-blind trial of 3 versus 6 months of nafarelin therapy for endometriosis associated pelvic pain

Mark D. Hornstein, Hornstein MD, M D Hornstein, A. Albert Yuzpe, A A Yuzpe, Yuzpe AA, Burry KA, K A Burry, Kenneth A. Burry, Heinrichs LR, Le Roy Heinrichs, L R Heinrichs, Buttram VL Jr, Veasy L. Buttram, V L Buttram, E S Orwoll, Eric Orwoll, Orwoll ES
Fertility and sterility · 1995 · vol. 63(5) , pp. 955–962 · doi:10.1016/s0015-0282(16)57530-x · PMID:7720940 · W178615457
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This trial compared 3 months of nafarelin therapy to 6 months for endometriosis-associated pelvic pain.

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Abstract

ObjectivesTo determine the effectiveness of a 3-month course of nafarelin and, furthermore, to determine the long-term efficacy in patients treated for 3 and 6 months with nafarelin for symptoms associated with endometriosis.DesignDouble-blind, prospective, multicenter, clinical trial.SettingFifteen reproductive endocrine clinics throughout the United States.PatientsOne hundred seventy-nine women with pelvic pain and endometriosis.InterventionsPatients were assigned randomly to 3 months nafarelin followed by 3 months of placebo (n = 91) or to 6 months nafarelin (n = 88) in a prospective, randomized, double-blind multicenter trial. Patients were followed for 12 months after cessation of therapy.Main outcome measuresPatient-reported pain scores and physician-reported physical exam findings.ResultsPain scores dropped significantly by the end of treatment in both groups. Symptoms recurred in both groups, and pain scores gradually increased during the follow-up period but always remained below baseline in both groups. No significant difference in efficacy was noted between the groups. A total of 26% of patients in each group underwent retreatment for recurrent symptoms.ConclusionsA 3-month course of nafarelin provided effective symptom relief for endometriosis. One year follow-up demonstrated continued pain relief but with gradual return of symptoms.

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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Nafarelin Pelvic Pain Adult Double-Blind Method Endometriosis Estradiol Estradiol Female Humans Nafarelin Nafarelin Pelvic Pain Pelvic Pain Placebos Prospective Studies Recurrence

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