Prospective randomized double-blind trial of 3 versus 6 months of nafarelin therapy for endometriosis associated pelvic pain
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⤵ 114 in-corpus citations
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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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- Does Helica treatment of early endometriosis confer short- and long-term benefits in terms of pain relief and sub-fertility? 2013
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- Integrated pharmacometrics and systems pharmacology model-based analyses to guide GnRH receptor modulator development for management of endometriosis 2012
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- Preoperative pain and recurrence risk in patients with peritoneal endometriosis 2010
- An investigation of the surgical treatment of endometriosis 2010
- Gonadotrophin-releasing hormone analogues for pain associated with endometriosis 2010
- [Current aspects on diagnosis and treatment of endometriosis] 2010
- Chronische Endometriose: medikamentöse Therapie 2010
- The efficacy and tolerability of short-term low-dose estrogen-only add-back therapy during post-operative GnRH agonist treatment for endometriosis 2010
- L'endométriose en 2009: place respective du traitement médical et du traitement chirurgical. 2009
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