Gonadotropin-releasing hormone agonist plus add-back hormone replacement therapy for treatment of endometriosis: a prospective, randomized, placebo-controlled, double-blind trial

Objective: To assess the effect of add-back therapy with continuous combined estrogen-progestin on the GnRH agonist-induced hypoestrogenic state and its effectiveness in healing of endometriotic lesions. Design: A prospective, randomized, placebo-controlled, double-blind trial. Setting: Multiple centers in The Netherlands. Patient(s): 41 premenopausal women with laparoscopically diagnosed endometriosis (revised American Fertility Society scores greater than or equal to 2). Intervention(s): Patients were randomly assigned to receive a subcutaneous depot formulation of goserelin, 3.6 m. every 4 weeks, plus oral placebo or oral continuous combined estradiol-norethisterone acetate add-back therapy daily for 24 weeks. Main Outcome Measure(s): Endometriosis response, bone mineral density, transvaginal ultrasonographic changes, endocrinologic effects, and subjective side effects. Result(s): The number of endometriotic implants was significantly reduced in both groups. In the group that received GnRH agonist plus placebo, bone mineral density of the lumbar spins decreased by 5.02%. Conclusion(s): The effectiveness of GnRH agonist treatment for endometriosis was not decreased by the addition of a back continuous combined hormone replacement therapy. Bone mineral density of the lumbar spine was maintained and subjective side effects were diminished, (Fertil Steril(R) 2000,74,534-9. (C) 2000 by American Society for Reproductive Medicine.).