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.
RCT Entities:
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.
Authors: U Ulrich; O Buchweitz; R Greb; J Keckstein; I von Leffern; P Oppelt; S P Renner; M Sillem; W Stummvoll; R-L De Wilde; K-W Schweppe Journal: Geburtshilfe Frauenheilkd Date: 2014-12 Impact factor: 2.915
Authors: U Ulrich; O Buchweitz; R Greb; J Keckstein; I von Leffern; P Oppelt; S P Renner; M Sillem; W Stummvoll; K-W Schweppe Journal: Geburtshilfe Frauenheilkd Date: 2013-09 Impact factor: 2.915
Authors: I Juhasz-Böss; M W Laschke; F Müller; P Rosenbaum; S Baum; E F Solomayer; U Ulrich Journal: Geburtshilfe Frauenheilkd Date: 2014-08 Impact factor: 2.915