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

Abstract

To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain. Prospective, randomized, double-blind controlled trial. Academic medical centers in Rochester, New York, and Boston, Massachusetts. Forty-seven women with endometriosis-associated pelvic pain. 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. Biberoglu and Behrman (B&B) pain scores, numerical rating scores (NRS), Beck Depression Inventory (BDI), and Index of Sexual Satisfaction (ISS). 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. Leuprolide and continuous oral contraceptives appear to be equally effective in the treatment of endometriosis-associated pelvic pain.