title: An open randomized comparative study of the effect of goserelin depot and danazol in the treatment of endometriosis. Zoladex Endometriosis Study Team.
abstract: OBJECTIVE
  To compare the efficacy and safety of goserelin depot and danazol for endometriosis.
  
  
  METHODS
  Open, randomized comparative trial.
  
  
  METHODS
  Multicenter European academic clinical institutions.
  
  
  METHODS
  A total of 307 patients with laparoscopically diagnosed endometriosis were randomized to goserelin (n = 204) or danazol (n = 103); 249 patients underwent second look laparoscopy (175 received goserelin and 74 danazol) and were analyzed for efficacy.
  
  
  METHODS
  A 3.6-mg depot of goserelin monthly subcutaneously or oral danazol 200 mg three times a day administered for 24 weeks.
  
  
  METHODS
  Efficacy assessments were based on changes in visible deposits at laparoscopy before and after treatment and subjective symptom scores at 4-week intervals during treatment and 8-week intervals after treatment for up to 24 weeks. Safety was assessed by adverse event reporting and clinical laboratory measures.
  
  
  RESULTS
  There were similar proportions of symptomatic (73%) and asymptomatic (but infertile) (27%) and comparable distribution of different severity of endometriosis randomized to each treatment. Significantly fewer patients randomized to goserelin (6.4%) withdrew during treatment compared with 20.4% randomized to danazol (P less than 0.05). There were significantly reduced visible deposits of endometriosis found post-treatment (P less than 0.0001) within each group but no differences between the treatments. The mean total subjective symptoms scores remained significantly less than entry at 24 weeks post-treatment (P less than 0.05). Hypoestrogenic side effects were more common in those receiving goserelin, particularly hot flushes, but anabolic/androgenic side effects of weight gain and muscle cramps were more common in those receiving danazol.
  
  
  CONCLUSIONS
  The monthly administered 3.6-mg depot preparation of goserelin was highly effective at inducing resolution of endometriotic implants and relieving the symptoms of endometriosis with prevention of their return during 24 weeks follow-up in the majority of patients. However, results were not significantly different from those achieved with danazol 600 mg/d.
authors.affiliation: Academic Department of Obstetrics and Gynaecology, Royal Free Hospital School of Medicine, London, United Kingdom.
authors.forename: R W
authors.initials: RW
authors.lastname: Shaw
mesh_terms: D000293:Adolescent; D000328:Adult; D002064:Buserelin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003613:Danazol / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004715:Endometriosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D005260:Female; D017273:Goserelin; D006801:Humans; D008598:Menstruation; D011247:Pregnancy
chemical_list: D003692:Delayed-Action Preparations; D017273:Goserelin; D003613:Danazol; D002064:Buserelin