Hum. Reprod. Advance Access originally published online on September 21, 2005
Human Reproduction 2006 21(1):248-256; doi:10.1093/humrep/dei290
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Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain
1 Director, I Clinica Ostetrica e Ginecologica - Università di Milano, Via Commenda 12 20122 Milano, Italy, 2 University of Connecticut School of Medicine, New Britain General Hospital, 100 Grand Street, New Britain, CT 06050, United States, 3 Pfizer Inc, East 42nd St 150/11/62S New York, NY 10017, United States and 4 Karolinska Institutet, Department of Obstetrics and Gynaecology, Danderyds Hospital, SE-182 88 Stockholm, Sweden
5 To whom correspondence should be addressed: amrit.ray{at}pfizer.com
BACKGROUND: A clinical study compared efficacy and safety of depot medroxyprogesterone acetate (DMPA) with leuprolide for endometriosis-associated pain. METHODS: This multicentre, 18 month, evaluator-blinded, comparator-controlled trial randomized 300 women with laparoscopically diagnosed endometriosis to 6 month treatment with subcutaneous injection of 104 mg/0.65 ml DMPA (DMPA-SC 104) every 3 months or leuprolide (3.75 mg monthly or 11.25 mg every 3 months), with 12 months post-treatment follow-up. Endpoints included patient response to treatment in five signs/symptoms (dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness, induration) and changes in bone mineral density (BMD) and productivity at 6 and 18 months. RESULTS: DMPA-SC 104 and leuprolide produced equivalent (P < 0.02) reductions in at least four pain categories and significant (P < 0.001) improvements in composite score at months 6 and 18. At month 6, reductions in total hip and lumbar spine BMD were significantly less (P < 0.001) with DMPA-SC 104 versus leuprolide. BMD returned to pre-treatment levels 12 months post-treatment in the DMPA-SC 104 but not the leuprolide group. Total productivity also significantly (P
0.05) improved in both groups at 6 and 18 months. CONCLUSIONS: DMPA-SC 104 reduces endometriosis-associated pain as effectively as leuprolide and improves productivity with significantly less BMD decline.
Key words: bone mineral density/depot medroxyprogesterone acetate/subcutaneous injection/endometriosis/leuprolide/pelvic pain
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