Randomized trial of leuprolide versus continuous oral contraceptives in the treatment of endometriosis-associated pelvic pain

Abstract

Objective: To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain. Design: Prospective, randomized, double-blind controlled trial. Setting: Academic medical centers in Rochester, New York, and Boston, Massachusetts. Patient(s): Forty-seven women with endometriosis-associated pelvic pain. Intervention(s): Forty-eight weeks of either depot leuprolide, 11.25 mg IM every 12 weeks with hormonal add-back using norethindrone acetate 5 mg orally, daily; or a generic monophasic oral contraceptive (1 mg norethindrone + 35 mg ethinyl estradiol) given daily. Main Outcome Measure(s): Biberoglu and Behrman (B&B) pain scores, numerical rating scores (NRS), Beck Depression Inventory (BDI), and Index of Sexual Satisfaction (ISS). Result(s): Based on enrollment of 47 women randomized to continuous oral contraceptives and to leuprolide, there were statistically significant declines in B&B, NRS, and BDI scores from baseline in both groups. There were no significant differences, however, in the extent of reduction in these measures between the groups. Conclusion(s): Leuprolide and continuous oral contraceptives appear to be equally effective in the treatment of endometriosis-associated pelvic pain. Copyright © 2011 American Society for Reproductive Medicine, Published by Elsevier Inc.