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

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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

OBJECTIVES: To 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. DESIGN: Double-blind, prospective, multicenter, clinical trial. SETTING: Fifteen reproductive endocrine clinics throughout the United States. PATIENTS: One hundred seventy-nine women with pelvic pain and endometriosis. INTERVENTIONS: Patients 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 MEASURES: Patient-reported pain scores and physician-reported physical exam findings. RESULTS: Pain 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. CONCLUSIONS: A 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 Adult Double-Blind Method Double-Blind Method Endometriosis Endometriosis Estradiol Estradiol Estradiol Female Female Humans Humans Nafarelin Nafarelin Nafarelin Pelvic Pain

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References (17)

Cited by (50)

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europepmc
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