ZOLADEX (GOSERELIN ACETATE IMPLANT) IN THE TREATMENT OF ENDOMETRIOSIS- A RANDOMIZED COMPARISON WITH DANAZOL

Objective: To compare the efficacy, endocrine effects, and safety of Z oladex (goserelin acetate) and danazol in the treatment of premenopaus al women with endometriosis in a multicenter, randomized, open study. Methods: Three hundred fifteen patients with stages I-IV endometriosis (revised American Fertility Society [AFS] classification) were treate d with Zoladex, 3.6 mg every 28 days by subcutaneous injection, or dan azol, 400 mg orally twice daily for 24 weeks. Efficacy was assessed by determination of pelvic signs and symptoms scores and revised AFS end ometriosis scores. Endocrine effects were determined by measurements o f hormone levels. Safety was evaluated by physical examination, labora tory indices, occurrence of adverse events, and bone mineral density c hanges. Results: Both treatments significantly (P < .0001) reduced mea n subjective signs and symptoms scores both during and after therapy. The mean percent reduction in the revised AFS endometriosis score afte r 24 weeks of treatment was 53% for Zoladex and 33% for danazol, and r eduction in the endometrial implants score was 56% for Zoladex and 46% for danazol. Serum estradiol levels decreased to the postmenopausal r ange in the Zoladex group and to the early follicular phase range in t he danazol group. Hypoestrogenic effects occurred more frequently with Zoladex, whereas androgenic side effects were more common with danazo l. There was a higher percentage of withdrawals due to adverse events with danazol than with Zoladex. Mean bone mineral density decreased fr om baseline by 5.4% in the Zoladex group and increased by 1.0% in the danazol group at the end of treatment. Conclusion: Zoladex is as well tolerated and as effective as danazol in the treatment of premenopausa l women with endometriosis.