An open randomized comparative study of the effect of goserelin depot and danazol in the treatment of endometriosis. Zoladex Endometriosis Study Team.
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.
Shaw
R W
RW
Academic Department of Obstetrics and Gynaecology, Royal Free Hospital School of Medicine, London, United Kingdom.
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
D003692:Delayed-Action Preparations; D017273:Goserelin; D003613:Danazol; D002064:Buserelin