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


METHODS
Double-blind, prospective, multicenter, clinical trial.


METHODS
Fifteen reproductive endocrine clinics throughout the United States.


METHODS
One hundred seventy-nine women with pelvic pain and endometriosis.


METHODS
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.


METHODS
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.
Hornstein
M D
MD
Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Yuzpe
A A
AA
Burry
K A
KA
Heinrichs
L R
LR
Buttram
V L
VL
Orwoll
E S
ES
D000328:Adult; D004311:Double-Blind Method; D004715:Endometriosis / Q000150:complications*; D004958:Estradiol / Q000097:blood; D005260:Female; D006801:Humans; D017274:Nafarelin / Q000008:administration & dosage / Q000627:therapeutic use*; D017699:Pelvic Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D011446:Prospective Studies; D012008:Recurrence
D010919:Placebos; D017274:Nafarelin; D004958:Estradiol