Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density

• Published in: Contraception (Stoneham) 2009-07, Vol.80 (1), p.7-17
• Main Authors: Kaunitz, Andrew M, Darney, Philip D, Ross, Douglas, Wolter, Kevin D, Speroff, Leon
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Biological and medical sciences; Birth control; Bone density; Bone Density - drug effects; Contraceptive; Contraceptive Agents, Female - administration & dosage; Contraceptive Agents, Female - adverse effects; Contraceptive Agents, Female - pharmacokinetics; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Depot medroxyprogesterone acetate; Estradiol - blood; Female; Genital system. Reproduction; Gynecology. Andrology. Obstetrics; Hormonal contraception; Humans; Injections, Intramuscular; Injections, Subcutaneous; Medical sciences; Medroxyprogesterone Acetate - administration & dosage; Medroxyprogesterone Acetate - adverse effects; Medroxyprogesterone Acetate - pharmacokinetics; Metrorrhagia - chemically induced; Obstetrics and Gynecology; Patient Satisfaction; Pharmacology. Drug treatments; Pregnancy; Young Adult
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2009.02.005

Abstract Background A formulation of depot medroxyprogesterone acetate (DMPA) has been developed that allows subcutaneous injection (104 mg/0.65 mL; DMPA-SC) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA (150 mg/mL; DMPA-IM). Study Design This randomized, evaluator-blinded study was designed to compare efficacy, safety, and user satisfaction in women receiving DMPA-SC ( n =266) or DMPA-IM ( n =268) for 2 years with an option to continue for a third year. The primary objectives were to evaluate bone mineral density (BMD) changes and contraceptive efficacy after 2 years. Results A total of 225 women completed the first 2 years of this study (DMPA-SC, n =116; DMPA-IM, n =109). After 2 years of DMPA use, BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip (−3.3% and −3.6%, respectively) and lumbar spine (−4.3% and −5.0%, respectively). In those women who received DMPA during the third year, there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3. Recovery of BMD was observed in the small subpopulation of women who had discontinued DMPA-SC or DMPA-IM after the second year. The 2-year treatment-failure cumulative pregnancy rate was 0% in the DMPA-SC group and 0.8% (95% confidence interval, 0.00–2.37%) in the DMPA-IM group (life-table method). Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group. Conclusion DMPA-SC is an effective and well-tolerated contraceptive option, providing comparable efficacy and BMD safety to DMPA-IM.