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

AbstractOBJECTIVES:
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.
AuthorsM D Hornstein, A A Yuzpe, K A Burry, L R Heinrichs, V L Buttram Jr, E S Orwoll
JournalFertility and sterility (Fertil Steril) Vol. 63 Issue 5 Pg. 955-62 (May 1995) ISSN: 0015-0282 [Print] UNITED STATES
PMID7720940 (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

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