Md. Hornstein et al., PROSPECTIVE RANDOMIZED DOUBLE-BLIND TRIAL OF 3 VERSUS 6 MONTHS OF NAFARELIN THERAPY FOR ENDOMETRIOSIS-ASSOCIATED PELVIC PAIN, Fertility and sterility, 63(5), 1995, pp. 955-962
Objectives: To determine the effectiveness of a 3-month course of nafa
relin and, furthermore, to determine the long-term efficacy in patient
s treated for 3 and 6 months with nafarelin for symptoms associated wi
th endometriosis. Design: Double-blind, prospective, multicenter, clin
ical trial. Setting: Fifteen reproductive endocrine clinics throughout
the United States. Patients: One hundred seventy-nine women with pelv
ic pain and endometriosis. Interventions: Patients were assigned rando
mly to 3 months nafarelin followed by 3 months of placebo (n = 98) or
to 6 months nafarelin (n = 88) in a prospective, randomized, double-bl
ind multicenter trial. Patients were followed for 12 months after cess
ation of therapy. Main Outcome Measures: Patient-reported pain scores
and physician-reported physical exam findings. Results: Pain scores dr
opped significantly by the end of treatment in both groups. Symptoms r
ecurred in both groups, and pain scores gradually increased during the
follow-up period but always remained below baseline in both groups. N
o significant difference in efficacy was noted between the groups. A t
otal of 26% of patients in each group underwent retreatment for recurr
ent symptoms. Conclusions: A 3-month course of nafarelin provided effe
ctive symptom relief for endometriosis. One year follow-up demonstrate
d continued pain relief but with gradual return of symptoms.