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

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.

journal_name

Fertil Steril

journal_title

Fertility and sterility

authors

Hornstein MD,Yuzpe AA,Burry KA,Heinrichs LR,Buttram VL Jr,Orwoll ES

subject

Has Abstract

pub_date

1995-05-01 00:00:00

pages

955-62

issue

5

eissn

0015-0282

issn

1556-5653

pii

S0015-0282(16)57530-X

journal_volume

63

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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