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.

• Authors: M D Hornstein, A A Yuzpe, K A Burry, L R Heinrichs, V L Buttram Jr, E S Orwoll
• Journal: Fertility and sterility (Fertil Steril) Vol. 63 Issue 5 Pg. 955-62 (May 1995) ISSN: 0015-0282 [Print] United States
• PMID: 7720940 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Nafarelin
• Estradiol

Topics

• Adult
• Double-Blind Method
• Endometriosis (complications)
• Estradiol (blood)
• Female
• Humans
• Nafarelin (administration & dosage, therapeutic use)
• Pelvic Pain (drug therapy, etiology)
• Placebos
• Prospective Studies
• Recurrence