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

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.