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Hum. Reprod. Advance Access published online on September 21, 2005
Human Reproduction, doi:10.1093/humrep/dei290
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.
Received May 6, 2005
Revised August 4, 2005
Accepted August 8, 2005

Article

Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain

P.G. Crosignani 1, A. Luciano 2, A. Ray 3*, and A. Bergqvist 4

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
4 Karolinska Institutet, Department of Obstetrics and Gynaecology, Danderyds Hospital, SE-182 88 Stockholm, Sweden

* To whom correspondence should be addressed.
A. Ray, E-mail: amrit.ray{at}pfizer.com


  Abstract

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.

Keywords: bone mineral density/depot medroxyprogesterone acetate/subcutaneous injection/endometriosis/leuprolide/pelvic pain.
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