COMPARISON OF THE GONADOTROPIN-RELEASING-HORMONE AGONIST GOSERELIN ACETATE ALONE VERSUS GOSERELIN COMBINED WITH ESTROGEN-PROGESTOGEN ADD-BACK THERAPY IN THE TREATMENT OF ENDOMETRIOSIS

Objective: To investigate whether the addition of low-dose estrogen-P combination hormone replacement therapy (HRT) to GnRH agonist (GnRH-a) treatment for endometriosis reduces the pharmacologic side effects of such treatment without reducing efficacy and to determine the endocri nologic changes during treatment. Design: Prospective, randomized, dou ble-blind, placebo-controlled, comparative study of two drug regimens: 3.6 mg goserelin acetate in a 28-day SC depot formulation once monthl y for 6 months plus either a combination of 2 mg 17 beta-E(2) and 1 mg norethisterone acetate (NET) 1 mg or matching placebo tablets once da ily for 6 months. Setting: Multicenter study in three tertiary referra l centers at university teaching hospitals and two central hospitals. Patients: Women with laparoscopically confirmed symptomatic endometrio sis were included in the study. Results: Of the total of 109 patients screened, 93 were recruited and 88 patients were randomized to either the HRT or the placebo group. Four women were withdrawn because of var ious medical reasons, and 76 patients were followed-up for a total of 12 months. In terms of efficacy, there was no difference between the t wo drug regimens for objective or subjective response. There were sign ificantly less postmenopausal symptoms in the patients treated with go serelin plus HRT compared with those treated with goserelin plus place bo. Conclusion: Goserelin diminished significantly the symptoms and la paroscopic scores of endometriosis. The addition of HRT did not reduce the efficacy of goserelin but diminished the postmenopausal symptoms during treatment.